Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-30 @ 7:03 PM
Study NCT ID:
NCT00361257
Status:
TERMINATED
Last Update Posted:
2016-02-05
First Post:
2006-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Minocycline for the Treatment of Decreased Mental Function in HIV-Infected Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008911', 'term': 'Minocycline'}, {'id': 'D013752', 'term': 'Tetracycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ACTGCT.Gov@s-3.com', 'phone': '(301) 628-3313', 'title': 'ACTG Clinicaltrials.gov Coordinator', 'organization': 'ACTG Network Coordinating Center, Social and Scientific Systems, Inc.'}, 'certainAgreement': {'otherDetails': 'In accordance with the Clinical Trial Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Originally, 100 participants were expected to enroll. As of the early termination notice, 107 participants were randomized, yet not all subjects could complete the 24 week assessment.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 48 weeks since the randomization.', 'eventGroups': [{'id': 'EG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours', 'otherNumAtRisk': 52, 'otherNumAffected': 18, 'seriousNumAtRisk': 52, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours', 'otherNumAtRisk': 55, 'otherNumAffected': 34, 'seriousNumAtRisk': 55, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Sob', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhea/Loose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Blood amylase increased', 'notes': 'Grade 4: Life-threatening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vocal cord paralysis', 'notes': 'Amyotrophic lateral sclerosis (ALS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Renal failure', 'notes': 'Requires dialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Basal cell carcinoma', 'notes': 'On nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tooth infection', 'notes': 'Tooth discoloration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Suicidal ideation', 'notes': 'Resulted in hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Suicidal attempt', 'notes': 'By medication overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Cognitive Performance Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.651', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.064', 'ciLowerLimit': '-0.258', 'ciUpperLimit': '0.386', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.164', 'estimateComment': 'The total number used for the statistical analysis was 107 (52 in the minocycline arm and 55 in the placebo arm).', 'groupDescription': 'The null hypothesis was that the 24-week change of NPZ-8 in the minocycline group was the same as the one in the placebo group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model was adjusted for stratification variables, the CNS penetration score, and the baseline NPZ-8 score.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and week 24', 'description': 'Th cognitive performance is measured by NPZ-8. NPZ-8 is defined as the average of age and education adjusted z-scores of eight neuropsychological tests subcomponents in the neuropsychological test battery. These eight tests are:\n\n1. Grooved Pegboard Dominant Hand (GPD)\n2. Grooved Pegboard Non-dominant hand (GPN)\n3. Choice Reaction Time (CRT)\n4. Sequential Reaction Time (QRT)\n5. Timed Gait (TIG)\n6. Trail Making Part A (TMA)\n7. Trail Making Part B (TMB)\n8. Symbol Digit (SYD) The primary outcome is NPZ-8 score at week24 - NPZ-8 score at baseline.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The descriptive statistics above were based on the observed data; however, the statistical analysis was conducted by the ITT analysis and the missing outcomes at week 24 were imputed based on multiple regression imputations.'}, {'type': 'SECONDARY', 'title': 'Change in Global Deficit Z-Score (GDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.434', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.091', 'ciLowerLimit': '-0.140', 'ciUpperLimit': '0.323', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.116', 'groupDescription': 'The null hypothesis was that the 24-week changes in Global Deficit Score (GDS) between the minocycline and placebo groups are the same.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model was adjusted for stratification variables, the CNS penetration score, and the baseline GDS score.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and week 24', 'description': 'GDS on the test battery is the simple average of all 14 individual deficit scores in the test battery, including Time Gait, Grooved Pegboard Test for the dominant and non-dominant hands, Trail Making Test parts A and B, Symbol Digit Test, simple and sequential reaction time - CalCAP, Hopkins Verbal Learning Test (Revised)- Learning, Delayed Recall and Recognition trials, and Stroop Color Interference Test-color, word, and interference tasks. The outcome is the 24 week change of GDS Z-score (24 week-baseline).', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the observed data.'}, {'type': 'SECONDARY', 'title': "Change in Investigator's Clinical Global Impression Score (ICGIS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'classes': [{'title': 'Worsened', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.337', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.569', 'ciLowerLimit': '0.625', 'ciUpperLimit': '3.936', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.469', 'groupDescription': "The null hypothesis is that the 24 week changes of participants' clinical status in the minocycline group were the same as the ones in the placebo group based on ICGIS.", 'statisticalMethod': 'Regression, Cumulative Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model was adjusted for the stratification variables and the CNS penetration score.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At week 24', 'description': 'Clinicians were asked to rate their overall impression about the clinical improvement or worsening of his/her study participants. They can choose from the following 7 levels: (0) No Change, (1) Mild Improvement, (2) Moderate Improvement, (3) Marked Improvement, (4) Mild Worsening, (5) Moderate Worsening, and (6) Marked Worsening.\n\nFor the analysis, we simplified the outcome into the following 3 levels: (0) worsened, (1) No Change, and (2) Improved.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on observed data.'}, {'type': 'SECONDARY', 'title': 'Change in Cognitive Gross Motor Function Domain Z-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '0.22', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '2.68', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.243', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.502', 'ciLowerLimit': '-0.349', 'ciUpperLimit': '1.354', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.428', 'groupDescription': 'The null hypothesis is that the 24 week change in the cognitive gross motor function domain score in the minocycline group is the same as the one in the placebo group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model was adjusted for the stratification variables, the CNS penetration score, and the baseline cognitive gross motor function domain score.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and week 24', 'description': 'The cognitive gross motor function is a age and education adjusted z score of Timed Gait (TIG). The outcome is the 24 week change of cognitive gross motor function domain z-scores (week 24-baseline).', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the observed data.'}, {'type': 'SECONDARY', 'title': 'Change in Fine Motor Function Domain Z-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.059', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.293', 'ciLowerLimit': '-0.011', 'ciUpperLimit': '0.596', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.153', 'groupDescription': 'The null hypothesis was that the 24 week change in fine motor function domain score in the minocycline group was the same as the one in the placebo group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model was adjusted for the stratification variables, the CNS penetration score, and the baseline fine motor function domain score.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and week 24', 'description': 'The fine motor function domain score is an average of age, sex, education, and African-American ethnicity adjusted z scores of Grooved Pegboard Dominant Hand (GPD) and Grooved Pegboard Non-dominant hand (GPN). The outcome is a 24 week change of the fine motor function domain z-score (week 24-baseline).', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on observed data.'}, {'type': 'SECONDARY', 'title': 'Change in Psychomotor Function Domain Z-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.572', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.083', 'ciLowerLimit': '-0.375', 'ciUpperLimit': '0.209', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.147', 'groupDescription': 'The null hypothesis was that the 24 change of psychomotor function domain score in the minocycline group is the same as in the placebo group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model was adjusted for stratified variables, the baseline CNS penetration score, and the baseline psychomotor function domain score.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and week 24', 'description': 'The psychomotor function domain score us the average of age, sex, education, and African-American ethnicity adjusted z scores of Trail Making Part A (TMA) and Trail Making Part B (TMB). The outcome is the 24 week change of psychomotor function domain z-scores (week24-baseline).', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on observed data.'}, {'type': 'SECONDARY', 'title': 'Change in Fine Motor/Nonverbal Function Domain Z-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.637', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.086', 'ciLowerLimit': '-0.449', 'ciUpperLimit': '0.276', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.182', 'groupDescription': 'The null hypothesis was that the 24 week change of fine motor/nonverbal function domain score in the minocycline group was the same as in the placebo group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model was adjusted for the stratification variables, the CNS penetration score, and the baseline fine motor/nonverbal function domain score.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and week 24', 'description': 'The fine motor/nonverbal function domain score is a age and education adjusted z score of Symbol Digit Test (SYD) The outcome is the 24 change of fine motor/nonverbal function domain z-score (week 24-baseline).', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on observed data.'}, {'type': 'SECONDARY', 'title': 'Change in Information Processing Function Domain Z-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '1.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.754', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.074', 'ciLowerLimit': '-0.544', 'ciUpperLimit': '0.396', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.236', 'groupDescription': 'The null hypothesis was that the 24 week change of information processing function domain score in the minocycline group was the same as the one in the placebo group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model was adjusted for the stratification variables, the CNS penetration score, and the baseline information processing function domain score.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and week 24', 'description': 'The information processing function domain score is the average of age and education adjusted z scores of simple and sequential reaction time - CalCAP. The outcome is the 24 week change of information processing function domain z-scores (week 24-baseline).', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on observed data.'}, {'type': 'SECONDARY', 'title': 'Change in Verbal Memory Domain Z-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '0.18', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '1.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.484', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.145', 'ciLowerLimit': '-0.266', 'ciUpperLimit': '0.558', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.207', 'groupDescription': 'The null hypothesis was that the 24 week change of verbal memory domain score in the minocycline group was the same as the one in the placebo group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline verbal memory domain score.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and week 24', 'description': 'The verbal memory domain score is the average of age and education adjusted z scores of Hopkins Verbal Learning Test- Revised, Learning and Delayed Recall. The outcome is the 24 week change of verbal memory domain z-scores (week 24-baseline).', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on observed data.'}, {'type': 'SECONDARY', 'title': 'Change in Frontal Systems Function Domain Z-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.467', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.126', 'ciLowerLimit': '-0.467', 'ciUpperLimit': '0.216', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.172', 'groupDescription': 'The null hypothesis was that the 24 week change of frontal systems function domain score in the minocycline group was the same as the one in the placebo group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline frontal systems function domain score.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and week 24', 'description': 'The frontal systems function domain score is the average of age and education adjusted z scores of Stroop Color Interference Test (CTP) and interference task (STP). The outcome is the 24 week change of frontal systems function domain z-score (week 24-baseline).', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on observed data.'}, {'type': 'SECONDARY', 'title': 'Change in Karnofsky Performance Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'classes': [{'title': 'No Change/Worse', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Better', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.234', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.476', 'ciLowerLimit': '0.575', 'ciUpperLimit': '10.668', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.048', 'groupDescription': 'The null hypothesis was that the proportion of being "better" at 24 weeks in minocycline group was the same as in the placebo group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model was adjusted for the CNS penetration score. The stratification variables could not be included in the model since the model fit was poor.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline and week 24', 'description': 'The original Karnofsky performance score is 11 level score which ranges between 0 to 100. The score 100 means normal and 0 means death; therefore, higher score means higher ability to perform daily tasks.\n\nFor the analysis, a new dichotomous variable (no change/worse vs. better at 24 weeks compared to baseline) was created.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on observed data.'}, {'type': 'SECONDARY', 'title': 'Changes in Cluster of Differentiation 4 (CD4) Cell Counts (24 Weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '24.10', 'spread': '141.22', 'groupId': 'OG000'}, {'value': '8.24', 'spread': '143.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.574', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.09', 'ciLowerLimit': '-48.26', 'ciUpperLimit': '86.44', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '33.75', 'groupDescription': 'The null hypothesis was that the 24 week change in CD4 cell counts in the minocycline group was the same as the one in the placebo group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model was adjusted for stratification variables, the baseline CNS score, and the baseline CD4 cell count.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and weeks 24', 'description': 'The outcome was the 24 week change in CD4 cell count (week 24-baseline).', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on observed data.'}, {'type': 'SECONDARY', 'title': 'Changes in Cluster of Differentiation 8 (CD8) Cell Counts (24 Weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '43.90', 'spread': '244.51', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '253.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.502', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.43', 'ciLowerLimit': '-79.12', 'ciUpperLimit': '159.97', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '59.91', 'groupDescription': 'The null hypothesis was that the 24 week change in CD8 cell count in the minocycline group was the same as the one in the placebo group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline CD8 cell counts.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and week 24', 'description': 'The outcome was the 24 week change of CD8 cell counts (week 24-baseline).', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on observed data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Grade 2 or Higher Toxicity and/or Signs and Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'classes': [{'title': '0 - 4 weeks', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': '4.01 - 12 weeks', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '12.01 - 24 weeks', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '24.01 - 48 weeks', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.967', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The null hypothesis was that the time to Grade 2 or higher toxicity and/or signs and symptoms in the minocycline group was the same as the one in the placebo group.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout study up to week 48', 'description': 'Grade or higher means that adverse events were moderate, severe, or life-threatening, or death. Grade 2 or higher adverse events are lised in the Adverse Event section.', 'unitOfMeasure': 'participants with an event', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis includes all randomized participants. A total of 37 minocycline and 38 placebo participants reported Grade 2 or higher toxicity and/or signs and symptoms during 48 weeks.'}, {'type': 'SECONDARY', 'title': 'Change of HIV Plasma RiboNucleic Acid (RNA) Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'classes': [{'title': '>= 30 copies/mL at base, >= 30 at week 24', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '>= 30 copies/mL at base, < 30 at week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '< 30 copies/mL at base, >= 30 at week 24', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '< 30 copies/mL at base, < 30 at week 24', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline and week 24', 'description': 'The original scale of HIV RNA viral load is between 30 copies/mL to infinitive. The minimum score of 30 is the lowest detectable value. The summary table categorized this continuous value to a dichotomous variable (\\<30 copies/mL and \\>= 30 copies/mL).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The summary statistics were based on observed data. No statistical analysis was conducted.'}, {'type': 'SECONDARY', 'title': 'Changes in Instrumental Activities of Daily Living Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'classes': [{'title': 'No Change/Worse', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Better', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.890', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.071', 'ciLowerLimit': '0.405', 'ciUpperLimit': '2.837', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.497', 'groupDescription': 'The null hypothesis was that the proportion of participants who got better at week 24 compared to baseline in the minocycline group was the same as the one in the placebo group.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model was adjusted for the stratification variables and the baseline CNS penetration score.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline and week 24', 'description': 'The Instrumental Activities of Daily Living (IADL) questionnaire is designed to learn more about how subjects are able to perform common tasks. There are 16 common tasks. For each task, if the score at the time of evaluation is worse than the best in the past, an indicator of 1 is given. Otherwise, the indicator is 0. The overall IADL score is a sum of 16 indicators divided by 16; therefore, the range is between 0 and 1 and the lower score is better. The 24-week change of IADL score was changed into a categorical variable (no change/worse vs. better) at week 24 compare to baseline.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on observed data.'}, {'type': 'SECONDARY', 'title': 'Changes in Medication Management Test (Modified)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '2.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.304', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.405', 'ciLowerLimit': '-1.182', 'ciUpperLimit': '0.373', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.391', 'groupDescription': 'The null hypothesis was that the 24 change of medication management test score in the minocycline group was the same as the one in the placebo group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline medication management score.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and weeks 24', 'description': "The medication management test (modified) is designed to assess participants' medication management ability and their own medications and management. It's the number of how many times participants correctly answered 16 questions. The score ranges between 0 and 16, and higher score indicates better medication management.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on observed data.'}, {'type': 'SECONDARY', 'title': 'Changes in Protein Markers of Oxidative Stress (Unit = Counts Per Second Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Minocycline', 'description': '100 mg orally every 12 hours\n\nMinocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours'}, {'id': 'OG001', 'title': 'Arm 2: Matching Placebo', 'description': 'orally every 12 hours\n\nPlacebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours'}], 'classes': [{'title': 'Ceramides (counts per second)', 'categories': [{'measurements': [{'value': '0.0007', 'groupId': 'OG000', 'lowerLimit': '-0.0001', 'upperLimit': '0.0060'}, {'value': '-0.0051', 'groupId': 'OG001', 'lowerLimit': '-0.0177', 'upperLimit': '0.0006'}]}]}, {'title': 'Monohexosylceramides (counts per second)', 'categories': [{'measurements': [{'value': '0.0013', 'groupId': 'OG000', 'lowerLimit': '-0.0007', 'upperLimit': '0.0330'}, {'value': '-0.0066', 'groupId': 'OG001', 'lowerLimit': '-0.0279', 'upperLimit': '-0.0004'}]}]}, {'title': 'Dihydro Glycosyl Galceramides (counts per second)', 'categories': [{'measurements': [{'value': '0.0201', 'groupId': 'OG000', 'lowerLimit': '0.0043', 'upperLimit': '0.0355'}, {'value': '-0.0048', 'groupId': 'OG001', 'lowerLimit': '-0.0180', 'upperLimit': '-0.0010'}]}]}, {'title': 'Dihexosylceramides (counts per second)', 'categories': [{'measurements': [{'value': '0.0005', 'groupId': 'OG000', 'lowerLimit': '-0.0003', 'upperLimit': '0.0070'}, {'value': '-0.0043', 'groupId': 'OG001', 'lowerLimit': '-0.0090', 'upperLimit': '-0.0001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At pre-entry and Week 24', 'description': 'Protein marker of oxidative stress (Ceramides, Monohexosylceramides, Dihydro Glycosyl Galceramides, and Dihexosylceramides). For all markers, the outcome is the 24 week change (week 24-baseline).', 'unitOfMeasure': 'counts per second', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were willing to receive the lumber punctures at week 0 and 24.'}, {'type': 'SECONDARY', 'title': 'Changes in Markers of Oxidative Stress and Immune Activation (Unit=pg/mL Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Minocycline', 'description': '100 mg orally every 12 hours\n\nMinocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours'}, {'id': 'OG001', 'title': 'Arm 2: Matching Placebo', 'description': 'orally every 12 hours\n\nPlacebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours'}], 'classes': [{'title': 'Protein carbonyls (pg/ml)', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '3.32', 'upperLimit': '82.29'}, {'value': '13.2', 'groupId': 'OG001', 'lowerLimit': '0.13', 'upperLimit': '39.74'}]}]}, {'title': 'TNF-α (pg/mL)', 'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.31'}, {'value': '0.14', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.65'}]}]}, {'title': 'IL-6 (pg/mL)', 'categories': [{'measurements': [{'value': '-0.29', 'groupId': 'OG000', 'lowerLimit': '-0.67', 'upperLimit': '2.58'}, {'value': '0.95', 'groupId': 'OG001', 'lowerLimit': '-0.79', 'upperLimit': '2.41'}]}]}, {'title': 'CXCL8 (pg/mL)', 'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000', 'lowerLimit': '-3.07', 'upperLimit': '5.97'}, {'value': '-6.13', 'groupId': 'OG001', 'lowerLimit': '-12.5', 'upperLimit': '3.07'}]}]}, {'title': 'Hepatocyte growth factor (pg/mL)', 'categories': [{'measurements': [{'value': '16.09', 'groupId': 'OG000', 'lowerLimit': '-21.54', 'upperLimit': '168.99'}, {'value': '90.48', 'groupId': 'OG001', 'lowerLimit': '6.70', 'upperLimit': '250.39'}]}]}, {'title': 'Osteopontin (pg/mL)', 'categories': [{'measurements': [{'value': '-5208.94', 'groupId': 'OG000', 'lowerLimit': '-11579.90', 'upperLimit': '7088.79'}, {'value': '673.55', 'groupId': 'OG001', 'lowerLimit': '-14689.54', 'upperLimit': '23344.10'}]}]}, {'title': 'sFAS (pg/mL)', 'categories': [{'measurements': [{'value': '0.68', 'groupId': 'OG000', 'lowerLimit': '-9.35', 'upperLimit': '77.79'}, {'value': '134.1', 'groupId': 'OG001', 'lowerLimit': '26.41', 'upperLimit': '279.87'}]}]}, {'title': 'sFAS ligand (pg/mL)', 'categories': [{'measurements': [{'value': '-0.27', 'groupId': 'OG000', 'lowerLimit': '-0.65', 'upperLimit': '0.06'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '-0.07', 'upperLimit': '1.47'}]}]}, {'title': 'CXCL12 (pg/mL)', 'categories': [{'measurements': [{'value': '204.39', 'groupId': 'OG000', 'lowerLimit': '-164.20', 'upperLimit': '1152.41'}, {'value': '1,071.84', 'groupId': 'OG001', 'lowerLimit': '-96.75', 'upperLimit': '1678.84'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At pre-entry and Week 24', 'description': 'Protein markers of oxidative stress (Protein carbonyls) and markers of immune activation (TNF-a, IL-6,CXCL8, Hepatocyte growth factor, Osteopontin, sFAS, sFAS ligand, and CXCL12). For all markers, the outcome is the 24 week change (week 24-baseline).', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were willing to receive the lumber punctures at week 0 and 24.'}, {'type': 'SECONDARY', 'title': 'Changes in Markers of Oxidative Stress (Unit = Pixels/mm2 Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Minocycline', 'description': '100 mg orally every 12 hours\n\nMinocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours'}, {'id': 'OG001', 'title': 'Arm 2: Matching Placebo', 'description': 'orally every 12 hours\n\nPlacebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '-59.3', 'groupId': 'OG000', 'lowerLimit': '-76.05', 'upperLimit': '-36.69'}, {'value': '-3.04', 'groupId': 'OG001', 'lowerLimit': '-6.31', 'upperLimit': '59.86'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At pre-entry and Week 24', 'description': 'Protein marker of oxidative stress (Neurofilament heavy polypeptide). The outcome is the 24 week change (week 24-baseline).', 'unitOfMeasure': 'Pixels/mm^2', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were willing to receive the lumber punctures at week 0 and 24.'}, {'type': 'SECONDARY', 'title': 'Changes in Neurotransmitter Levels (Unit = uM Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Minocycline', 'description': '100 mg orally every 12 hours\n\nMinocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours'}, {'id': 'OG001', 'title': 'Arm 2: Matching Placebo', 'description': 'orally every 12 hours\n\nPlacebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours'}], 'classes': [{'title': 'Glutamate (uM)', 'categories': [{'measurements': [{'value': '5.09', 'groupId': 'OG000', 'lowerLimit': '-11.01', 'upperLimit': '13.41'}, {'value': '-1.08', 'groupId': 'OG001', 'lowerLimit': '-1.20', 'upperLimit': '10.88'}]}]}, {'title': 'Tryptophan (uM)', 'categories': [{'measurements': [{'value': '-0.21', 'groupId': 'OG000', 'lowerLimit': '-0.78', 'upperLimit': '0.12'}, {'value': '0.07', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '0.21'}]}]}, {'title': 'Anthranilic Acid (uM)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-2.25', 'upperLimit': '10.87'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.14', 'upperLimit': '6.15'}]}]}, {'title': 'Quinolinic Acid (uM)', 'categories': [{'measurements': [{'value': '-0.55', 'groupId': 'OG000', 'lowerLimit': '-7.94', 'upperLimit': '0.00'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-9.07', 'upperLimit': '4.11'}]}]}, {'title': 'Kynurenin (uM)', 'categories': [{'measurements': [{'value': '6.85', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '46.75'}, {'value': '6.97', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '23.90'}]}]}, {'title': '3-Hydroxykynurenine (uM)', 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-11.51', 'upperLimit': '0.02'}, {'value': '-0.83', 'groupId': 'OG001', 'lowerLimit': '-5.97', 'upperLimit': '0.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At pre-entry and Week 24', 'description': 'Neurotransmitter levels (Glutamate, Tryptophan, Anthranilic Acid, Quinolinic Acid, Kynurenin, and 3-Hydroxykynurenine). The outcome is the 24 week change (week 24-baseline).', 'unitOfMeasure': 'uM', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were willing to receive the lumber punctures at week 0 and 24.'}, {'type': 'SECONDARY', 'title': 'Changes in Alternate Psychomotor Function Z-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.506', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.097', 'ciLowerLimit': '-0.388', 'ciUpperLimit': '0.193', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.146', 'groupDescription': 'The null hypothesis was that the 24 week change in alternate psychomotor function score in the minocycline group was the same as the one in the placebo group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline alternate psychomotor function score.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and week 24', 'description': 'The alternate psychomotor function is defined as the mean of age, sex, education, and African-American ethnicity adjusted z scores of Trail Making Part A (TMA), and age and education adjusted z score of Symbol Digit (SYD). The outcome is the 24 week change in alternate psychomotor function z-score (week 24-baseline).', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the observed data.'}, {'type': 'SECONDARY', 'title': 'Changes in Alternate Verbal Memory Z-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '0.18', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '1.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.484', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.146', 'ciLowerLimit': '-0.266', 'ciUpperLimit': '0.558', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.207', 'groupDescription': 'The null hypothesis was that the 24 week change in the alternate verbal memory score in the minocycline group was the same as the one in the placebo group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model was adjusted for stratification variables, baseline CNS penetration score, and the baseline alternate verbal memory score.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and week 24', 'description': 'The alternate verbal memory was defined as a mean of age and education adjusted z score of trials 1 to 3 and delayed recall tests. The outcome is the 24 week change in alternate verbal memory z-score (week 24-baseline).', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is based on observed data.'}, {'type': 'SECONDARY', 'title': 'Changes in Alternate Frontal Systems Z-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'OG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.70', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.690', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.055', 'ciLowerLimit': '-0.217', 'ciUpperLimit': '0.327', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.137', 'groupDescription': 'The null hypothesis was the 24 week change of alternate frontal systems score in the minocycline group was the same as the one in the placebo group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model was adjusted for stratification variables, baseline CNS penetration score, and the baseline alternate frontal systems score.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and week 24', 'description': 'The alternate frontal systems was defined as a mean of age and education adjusted z score of Interference task, and age, sex, education, and African-American ethnicity adjusted z score of Trail Making Part B. The outcome was the 24 week change in alternate frontal systems z-score (week 24-baseline).', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on observed data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'FG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}], 'periods': [{'title': 'Step 1: Minocycline vs. Placebo', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}, {'title': 'Step 2: Minocycline(Open Label) for All', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '40 participants completed Step 1; however,12 decided not to enroll Step 2,so 40-12=28 started Step 2', 'groupId': 'FG000', 'numSubjects': '28'}, {'comment': '43 participants completed Step 1; however, 9 decided not to enroll Step 2,so 43-9=34 started Step 2.', 'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Minocycline', 'description': '100 mg orally every 12 hours'}, {'id': 'BG001', 'title': 'Matching Placebo', 'description': 'Placebo taken orally every 12 hours'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '7', 'groupId': 'BG000'}, {'value': '52', 'spread': '7', 'groupId': 'BG001'}, {'value': '51', 'spread': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cognitive Performance Score NPZ-8', 'classes': [{'categories': [{'measurements': [{'value': '-0.75', 'spread': '0.90', 'groupId': 'BG000'}, {'value': '-1.03', 'spread': '0.98', 'groupId': 'BG001'}, {'value': '-0.90', 'spread': '0.95', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Cognitive performance is measured by NPZ-8. The NPZ-8 is defined as the average of age and education adjusted z-scores of eight neuropsychological tests subcomponents in the neuropsychological test battery:\n\n1. Grooved Pegboard Dominant Hand (GPD)\n2. Grooved Pegboard Non-dominant hand (GPN)\n3. Choice Reaction Time (CRT)\n4. Sequential Reaction Time (QRT)\n5. Timed Gait (TIG)\n6. Trail Making Part A (TMA)\n7. Trail Making Part B (TMB)\n8. Symbol Digit (SYD)', 'unitOfMeasure': 'z-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Global Deficit Z-Score (GDS)', 'classes': [{'categories': [{'measurements': [{'value': '-0.86', 'spread': '0.72', 'groupId': 'BG000'}, {'value': '-1.08', 'spread': '0.90', 'groupId': 'BG001'}, {'value': '-0.97', 'spread': '0.82', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'GDS is defined as the average of age and education adjusted z-scores of 14 individual deficit scores in the test battery, including Time Gait, Grooved Pegboard Test for the dominant and non-dominant hands, Trail Making Test parts A and B, Symbol Digit Test, simple and sequential reaction time - CalCAP, Hopkins Verbal Learning Test (Revised)- Learning, Delayed Recall and Recognition trials, and Stroop Color Interference Test-color, word, and interference tasks.', 'unitOfMeasure': 'z-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cognitive Gross Motor Function Domain Z-Score', 'classes': [{'categories': [{'measurements': [{'value': '-2.44', 'spread': '3.10', 'groupId': 'BG000'}, {'value': '-3.66', 'spread': '4.16', 'groupId': 'BG001'}, {'value': '-3.06', 'spread': '3.71', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The cognitive gross motor function is age and education adjusted z-score of Timed Gait.', 'unitOfMeasure': 'z-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fine Motor Function Domain Z-Score', 'classes': [{'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.96', 'groupId': 'BG000'}, {'value': '-0.73', 'spread': '0.99', 'groupId': 'BG001'}, {'value': '-0.55', 'spread': '0.99', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This is an average z-scores of Grooved Pegboard Dominant and Non-Dominant Hand Tests adjusted for age, sex, education, and African-American ethnicity. The grooved pegboard is a manipulative dexterity test requiring rapid visual-motor coordination. The test is completed using the dominant hand (GPD) and then using the non-dominant hand (GPN). The score for each hand is the time in seconds that the participant takes to complete the entire board.', 'unitOfMeasure': 'z-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Psychomotor Function Domain Z-Score', 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'spread': '1.00', 'groupId': 'BG000'}, {'value': '0.04', 'spread': '1.03', 'groupId': 'BG001'}, {'value': '0.10', 'spread': '1.01', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This is an average of z-scores of Trail Making Part A (TMA) and Trail Making Part B (TMB) tests adjusted for age, sex, education, and African-American ethnicity. The TMA and TMB tests are measures of planning ability, visual-motor speed and concentration. Subjects are required to connect randomly placed numbers in sequence (1-25 for TMA) or to sequentially connect both numbers and letters while alternating back and forth (1-A-2-B-3-C-4-D etc. for TMB). Scores are the time in seconds required to complete the tasks.', 'unitOfMeasure': 'z-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fine Motor/Nonverbal Function Domain Z-Score', 'classes': [{'categories': [{'measurements': [{'value': '-1.11', 'spread': '1.15', 'groupId': 'BG000'}, {'value': '-1.24', 'spread': '1.18', 'groupId': 'BG001'}, {'value': '-1.18', 'spread': '1.16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "This score is a age and education adjusted z score of Symbol Digit Test (SYD). This test assesses the participant's ability to maintain rapid visual-motor sequencing in a timed test. The score is the total number of correctly transcribed numbers in the time limit (90 seconds). Participants receive 1 point for each item filled in correctly.", 'unitOfMeasure': 'z-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Information Processing Function Domain Z-Score', 'classes': [{'categories': [{'measurements': [{'value': '-1.05', 'spread': '1.52', 'groupId': 'BG000'}, {'value': '-1.03', 'spread': '1.49', 'groupId': 'BG001'}, {'value': '-1.04', 'spread': '1.50', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This is the average age and education adjusted z-scores of simple and sequential reaction time tests adjusted for age and education.', 'unitOfMeasure': 'z-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Verbal Memory Domain Z-Score', 'classes': [{'categories': [{'measurements': [{'value': '-1.33', 'spread': '1.16', 'groupId': 'BG000'}, {'value': '-1.41', 'spread': '1.12', 'groupId': 'BG001'}, {'value': '-1.37', 'spread': '1.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This is the average of z-scores of Hopkins Verbal Learning Test- Revised, Learning and Delayed Recall Tests adjusted for age and education. The recognition test list comprises 24 words, consisting of 12 words from the original list and 12 "distracters". The subject must answer "yes" if the word was from the list and "no" otherwise. Twenty minutes after the third list from verbal learning and immediate recall, delayed recall is assessed by asking the subject to recall as many words as possible from the list. The score is the number of words that are correctly recalled from the original list.', 'unitOfMeasure': 'z-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Frontal Systems Function Domain Z-Score', 'classes': [{'categories': [{'measurements': [{'value': '-0.79', 'spread': '0.98', 'groupId': 'BG000'}, {'value': '-1.05', 'spread': '1.57', 'groupId': 'BG001'}, {'value': '-0.92', 'spread': '1.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This is the average age and education adjusted z-scores of Stroop Color Interference Test (CTP) and interference task (STP). The Stroop Task is a measure of divided attentional abilities. Performance is measured by the amount of time required to read each of three cards: (1) blocks of colors, (2) names of colors, and (3) colored words. For each task, the time (in seconds) is the score that should be recorded on the form. A task that cannot be completed in 240 seconds is scored as incomplete.', 'unitOfMeasure': 'z-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Karnofsky Score', 'classes': [{'title': '70', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': '80', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': '90', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': '100', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Karnofsky performance score is ranged from 100 to 0:\n\n100: Normal; 90: Able to Carry on normal Activity; 80: Normal Activity with Effort; Some Signs or Symptoms of Disease; 70: Cares for Self, Unable to Carry on Normal Activity or to Do Active Work; 60: Requires Occasional Assistance but is Able to Care for Most of Needs; 50: Requires Considerable Assistance and Frequent Medical Care; 40: Disabled, Requires Special Care and Assistance; 30: Severely Disabled; Hospitalization Indicated Although Death is Not Imminent; 20: Very Sick; 10: Morbibund, Fatal Processes Progressing Rapidly; 0: Death', 'unitOfMeasure': 'participants'}, {'title': 'Cluster of Differentiation 4 (CD4)', 'classes': [{'categories': [{'measurements': [{'value': '551.65', 'spread': '312.96', 'groupId': 'BG000'}, {'value': '535.49', 'spread': '253.11', 'groupId': 'BG001'}, {'value': '543.35', 'spread': '282.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'CD4 counts by group at baseline', 'unitOfMeasure': 'copies/mm^3', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cluster of Differentiation 8 (CD8)', 'classes': [{'categories': [{'measurements': [{'value': '925.58', 'spread': '370.48', 'groupId': 'BG000'}, {'value': '838.78', 'spread': '353.73', 'groupId': 'BG001'}, {'value': '880.96', 'spread': '362.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'CD8 counts by group at baseline', 'unitOfMeasure': 'copies/mm^3', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HIV-1 Plasma RiboNucleic Acid (RNA) Viral Loads', 'classes': [{'title': 'Plasma RNA VL >=30 copies/mL', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Plasma RNA VL < 30 copies/mL', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'HIV Plasma RNA viral load less than 30 copies/mL is undetectable, the values will be imputed as 30 copies/mL.', 'unitOfMeasure': 'participants'}, {'title': 'HIV-1 CerebroSpinal Fluid (CSF) RNA Viral Loads (VL)', 'classes': [{'title': 'CSF RNA VL >=30 copies/mL', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'CSF RNA VL <30 copies/mL', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'HIV CSF RNA viral load less than 30 copies/mL is undetectable, the values will be imputed as 30 copies/mL.', 'unitOfMeasure': 'participants'}, {'title': 'Central Nervous System (CNS) Penetration Score', 'classes': [{'categories': [{'measurements': [{'value': '7', 'spread': '3', 'groupId': 'BG000'}, {'value': '7', 'spread': '3', 'groupId': 'BG001'}, {'value': '7', 'spread': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The baseline CNS penetration score is calculated based on the revised CNS penetration-effectiveness ranks (provided by Dr. Scott Letendre). The score is simply a sum of the ranks of all drugs which participants took at baseline. The better the drug penetrates, the higher the score. The range of ranks are 1 to 4, so the CNS penetration score is integer numbers greater than 1.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stratification Variable 1 - CSF Viral Load (VL) - Pre-baseline', 'classes': [{'title': 'CSF RNA VL < 30 copies/mL', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'CSF RNA VL >= 30 copies/mL', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'No Lumbar Punctures (LPs)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants were stratified based on two factors. One is CSF HIV-1 RNA. This variable has three levels using the TaqMan assay in CSF: (1) HIV CSF RNA VLs ≥30 copies/mL (detectable), \\<30 copies/mL (Undetectable), or no lumbar punctures (LPs). The assessment was conducted BEFORE the baseline in order to use this information for randomization.', 'unitOfMeasure': 'participants'}, {'title': 'Stratification Variable 2 - Objective or subjective Neuropsychological test - Pre-baseline', 'classes': [{'title': 'Objective Neuropsychological (NP) Test', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Subjective NP Test', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The 2nd stratification factor is progressive neurocognitive decline defined by objective or subjective criteria at pre-baseline. A decline of at least 1.0 standard deviation below age-matched and education-matched controls on two or more independent tests or 2.0 standard deviations below age-matched and education-matched controls on one test within 1 year before entry is defined as objective decline. Otherwise, subjective neurocognitive decline is defined by the participant or family member or caregiver AND a Center for Epidemiological Studies Depression score \\<16 within 45 days before entry.', 'unitOfMeasure': 'participants'}, {'title': 'Instrumental Activities of Daily Living (IADL) Summary Score', 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '0.15', 'groupId': 'BG000'}, {'value': '0.13', 'spread': '0.16', 'groupId': 'BG001'}, {'value': '0.12', 'spread': '0.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The IADL questionnaire has 16 common tasks: 1. Housekeeping; 2.Managing Finances; 3. Buying Groceries; 4.Cooking; 5. Planning Social Activities; 6.Understanding Reading Materials/TV; 7.Transportation; 8.Using the Telephone; 9.Home Repairs; 10.Bathing; 11.Dressing; 12.Shopping; 13.Laundry; 14.Taking/Keeping Track of Medication; 15.Child Care; 16.Work. For each task, if the score at the time of evaluation is worse than the best in the past, an indicator of 1 is given; otherwise 0. The IADL score is a sum of 16 indicators divided by 16. The lower score indicates better. The range is from 0 to 1.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Medication Management Test (MMT) Score', 'classes': [{'categories': [{'measurements': [{'value': '14.72', 'spread': '1.41', 'groupId': 'BG000'}, {'value': '14.09', 'spread': '2.52', 'groupId': 'BG001'}, {'value': '14.39', 'spread': '2.08', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The medication management test (modified) is designed to assess participants' medication management ability and their own medications and management. It's the number of how many times participants correctly answered 16 questions.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Alternate Psychomotor Function Z-Score', 'classes': [{'categories': [{'measurements': [{'value': '-0.54', 'spread': '0.82', 'groupId': 'BG000'}, {'value': '-0.63', 'spread': '0.92', 'groupId': 'BG001'}, {'value': '-0.58', 'spread': '0.87', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This is the average of z scores of Trail Making Part A and Symbol Digit Tests. Trail Making Part A z score was adjusted for age, sex, education, and African-Ametrican ethnicity. Symbol Digit z score was adjusted for age and education.', 'unitOfMeasure': 'z-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Alternate Verbal Memory Z-Score', 'classes': [{'categories': [{'measurements': [{'value': '-1.33', 'spread': '1.16', 'groupId': 'BG000'}, {'value': '-1.41', 'spread': '1.12', 'groupId': 'BG001'}, {'value': '-1.37', 'spread': '1.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This is the average of age and education adjusted z scores of standardized trials 1 to 3 and delayed recall tests.', 'unitOfMeasure': 'z-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Alternate Frontal Systems Z-Score', 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.86', 'groupId': 'BG000'}, {'value': '-0.13', 'spread': '1.09', 'groupId': 'BG001'}, {'value': '-0.09', 'spread': '0.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This is average of z scores of standardized interference task and trailmaking part b tests. The interference task z score was adjusted for age and education. The trailmaking part b z score was adjusted for age, sex, education, and African-American ethnicity.', 'unitOfMeasure': 'z-score', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'whyStopped': 'This study was terminated early due to futility.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-07', 'studyFirstSubmitDate': '2006-08-04', 'resultsFirstSubmitDate': '2011-01-28', 'studyFirstSubmitQcDate': '2006-08-04', 'lastUpdatePostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-06-27', 'studyFirstPostDateStruct': {'date': '2006-08-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cognitive Performance Compared to Baseline', 'timeFrame': 'At baseline and week 24', 'description': 'Th cognitive performance is measured by NPZ-8. NPZ-8 is defined as the average of age and education adjusted z-scores of eight neuropsychological tests subcomponents in the neuropsychological test battery. These eight tests are:\n\n1. Grooved Pegboard Dominant Hand (GPD)\n2. Grooved Pegboard Non-dominant hand (GPN)\n3. Choice Reaction Time (CRT)\n4. Sequential Reaction Time (QRT)\n5. Timed Gait (TIG)\n6. Trail Making Part A (TMA)\n7. Trail Making Part B (TMB)\n8. Symbol Digit (SYD) The primary outcome is NPZ-8 score at week24 - NPZ-8 score at baseline.'}], 'secondaryOutcomes': [{'measure': 'Change in Global Deficit Z-Score (GDS)', 'timeFrame': 'At baseline and week 24', 'description': 'GDS on the test battery is the simple average of all 14 individual deficit scores in the test battery, including Time Gait, Grooved Pegboard Test for the dominant and non-dominant hands, Trail Making Test parts A and B, Symbol Digit Test, simple and sequential reaction time - CalCAP, Hopkins Verbal Learning Test (Revised)- Learning, Delayed Recall and Recognition trials, and Stroop Color Interference Test-color, word, and interference tasks. The outcome is the 24 week change of GDS Z-score (24 week-baseline).'}, {'measure': "Change in Investigator's Clinical Global Impression Score (ICGIS)", 'timeFrame': 'At week 24', 'description': 'Clinicians were asked to rate their overall impression about the clinical improvement or worsening of his/her study participants. They can choose from the following 7 levels: (0) No Change, (1) Mild Improvement, (2) Moderate Improvement, (3) Marked Improvement, (4) Mild Worsening, (5) Moderate Worsening, and (6) Marked Worsening.\n\nFor the analysis, we simplified the outcome into the following 3 levels: (0) worsened, (1) No Change, and (2) Improved.'}, {'measure': 'Change in Cognitive Gross Motor Function Domain Z-Score', 'timeFrame': 'At baseline and week 24', 'description': 'The cognitive gross motor function is a age and education adjusted z score of Timed Gait (TIG). The outcome is the 24 week change of cognitive gross motor function domain z-scores (week 24-baseline).'}, {'measure': 'Change in Fine Motor Function Domain Z-Score', 'timeFrame': 'At baseline and week 24', 'description': 'The fine motor function domain score is an average of age, sex, education, and African-American ethnicity adjusted z scores of Grooved Pegboard Dominant Hand (GPD) and Grooved Pegboard Non-dominant hand (GPN). The outcome is a 24 week change of the fine motor function domain z-score (week 24-baseline).'}, {'measure': 'Change in Psychomotor Function Domain Z-Score', 'timeFrame': 'At baseline and week 24', 'description': 'The psychomotor function domain score us the average of age, sex, education, and African-American ethnicity adjusted z scores of Trail Making Part A (TMA) and Trail Making Part B (TMB). The outcome is the 24 week change of psychomotor function domain z-scores (week24-baseline).'}, {'measure': 'Change in Fine Motor/Nonverbal Function Domain Z-Score', 'timeFrame': 'At baseline and week 24', 'description': 'The fine motor/nonverbal function domain score is a age and education adjusted z score of Symbol Digit Test (SYD) The outcome is the 24 change of fine motor/nonverbal function domain z-score (week 24-baseline).'}, {'measure': 'Change in Information Processing Function Domain Z-Score', 'timeFrame': 'At baseline and week 24', 'description': 'The information processing function domain score is the average of age and education adjusted z scores of simple and sequential reaction time - CalCAP. The outcome is the 24 week change of information processing function domain z-scores (week 24-baseline).'}, {'measure': 'Change in Verbal Memory Domain Z-Score', 'timeFrame': 'At baseline and week 24', 'description': 'The verbal memory domain score is the average of age and education adjusted z scores of Hopkins Verbal Learning Test- Revised, Learning and Delayed Recall. The outcome is the 24 week change of verbal memory domain z-scores (week 24-baseline).'}, {'measure': 'Change in Frontal Systems Function Domain Z-Score', 'timeFrame': 'At baseline and week 24', 'description': 'The frontal systems function domain score is the average of age and education adjusted z scores of Stroop Color Interference Test (CTP) and interference task (STP). The outcome is the 24 week change of frontal systems function domain z-score (week 24-baseline).'}, {'measure': 'Change in Karnofsky Performance Score', 'timeFrame': 'At baseline and week 24', 'description': 'The original Karnofsky performance score is 11 level score which ranges between 0 to 100. The score 100 means normal and 0 means death; therefore, higher score means higher ability to perform daily tasks.\n\nFor the analysis, a new dichotomous variable (no change/worse vs. better at 24 weeks compared to baseline) was created.'}, {'measure': 'Changes in Cluster of Differentiation 4 (CD4) Cell Counts (24 Weeks)', 'timeFrame': 'At baseline and weeks 24', 'description': 'The outcome was the 24 week change in CD4 cell count (week 24-baseline).'}, {'measure': 'Changes in Cluster of Differentiation 8 (CD8) Cell Counts (24 Weeks)', 'timeFrame': 'At baseline and week 24', 'description': 'The outcome was the 24 week change of CD8 cell counts (week 24-baseline).'}, {'measure': 'Number of Participants With Grade 2 or Higher Toxicity and/or Signs and Symptoms', 'timeFrame': 'Throughout study up to week 48', 'description': 'Grade or higher means that adverse events were moderate, severe, or life-threatening, or death. Grade 2 or higher adverse events are lised in the Adverse Event section.'}, {'measure': 'Change of HIV Plasma RiboNucleic Acid (RNA) Viral Load', 'timeFrame': 'At baseline and week 24', 'description': 'The original scale of HIV RNA viral load is between 30 copies/mL to infinitive. The minimum score of 30 is the lowest detectable value. The summary table categorized this continuous value to a dichotomous variable (\\<30 copies/mL and \\>= 30 copies/mL).'}, {'measure': 'Changes in Instrumental Activities of Daily Living Questionnaire', 'timeFrame': 'At baseline and week 24', 'description': 'The Instrumental Activities of Daily Living (IADL) questionnaire is designed to learn more about how subjects are able to perform common tasks. There are 16 common tasks. For each task, if the score at the time of evaluation is worse than the best in the past, an indicator of 1 is given. Otherwise, the indicator is 0. The overall IADL score is a sum of 16 indicators divided by 16; therefore, the range is between 0 and 1 and the lower score is better. The 24-week change of IADL score was changed into a categorical variable (no change/worse vs. better) at week 24 compare to baseline.'}, {'measure': 'Changes in Medication Management Test (Modified)', 'timeFrame': 'At baseline and weeks 24', 'description': "The medication management test (modified) is designed to assess participants' medication management ability and their own medications and management. It's the number of how many times participants correctly answered 16 questions. The score ranges between 0 and 16, and higher score indicates better medication management."}, {'measure': 'Changes in Protein Markers of Oxidative Stress (Unit = Counts Per Second Only)', 'timeFrame': 'At pre-entry and Week 24', 'description': 'Protein marker of oxidative stress (Ceramides, Monohexosylceramides, Dihydro Glycosyl Galceramides, and Dihexosylceramides). For all markers, the outcome is the 24 week change (week 24-baseline).'}, {'measure': 'Changes in Markers of Oxidative Stress and Immune Activation (Unit=pg/mL Only)', 'timeFrame': 'At pre-entry and Week 24', 'description': 'Protein markers of oxidative stress (Protein carbonyls) and markers of immune activation (TNF-a, IL-6,CXCL8, Hepatocyte growth factor, Osteopontin, sFAS, sFAS ligand, and CXCL12). For all markers, the outcome is the 24 week change (week 24-baseline).'}, {'measure': 'Changes in Markers of Oxidative Stress (Unit = Pixels/mm2 Only)', 'timeFrame': 'At pre-entry and Week 24', 'description': 'Protein marker of oxidative stress (Neurofilament heavy polypeptide). The outcome is the 24 week change (week 24-baseline).'}, {'measure': 'Changes in Neurotransmitter Levels (Unit = uM Only)', 'timeFrame': 'At pre-entry and Week 24', 'description': 'Neurotransmitter levels (Glutamate, Tryptophan, Anthranilic Acid, Quinolinic Acid, Kynurenin, and 3-Hydroxykynurenine). The outcome is the 24 week change (week 24-baseline).'}, {'measure': 'Changes in Alternate Psychomotor Function Z-Score', 'timeFrame': 'At baseline and week 24', 'description': 'The alternate psychomotor function is defined as the mean of age, sex, education, and African-American ethnicity adjusted z scores of Trail Making Part A (TMA), and age and education adjusted z score of Symbol Digit (SYD). The outcome is the 24 week change in alternate psychomotor function z-score (week 24-baseline).'}, {'measure': 'Changes in Alternate Verbal Memory Z-Score', 'timeFrame': 'At baseline and week 24', 'description': 'The alternate verbal memory was defined as a mean of age and education adjusted z score of trials 1 to 3 and delayed recall tests. The outcome is the 24 week change in alternate verbal memory z-score (week 24-baseline).'}, {'measure': 'Changes in Alternate Frontal Systems Z-Score', 'timeFrame': 'At baseline and week 24', 'description': 'The alternate frontal systems was defined as a mean of age and education adjusted z score of Interference task, and age, sex, education, and African-American ethnicity adjusted z score of Trail Making Part B. The outcome was the 24 week change in alternate frontal systems z-score (week 24-baseline).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Treatment Experienced'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '15569045', 'type': 'BACKGROUND', 'citation': 'Bell JE. An update on the neuropathology of HIV in the HAART era. Histopathology. 2004 Dec;45(6):549-59. doi: 10.1111/j.1365-2559.2004.02004.x.'}, {'pmid': '16471077', 'type': 'BACKGROUND', 'citation': 'Ferrari S, Vento S, Monaco S, Cavallaro T, Cainelli F, Rizzuto N, Temesgen Z. Human immunodeficiency virus-associated peripheral neuropathies. Mayo Clin Proc. 2006 Feb;81(2):213-9. doi: 10.4065/81.2.213.'}, {'pmid': '15855434', 'type': 'BACKGROUND', 'citation': 'Zink MC, Uhrlaub J, DeWitt J, Voelker T, Bullock B, Mankowski J, Tarwater P, Clements J, Barber S. Neuroprotective and anti-human immunodeficiency virus activity of minocycline. JAMA. 2005 Apr 27;293(16):2003-11. doi: 10.1001/jama.293.16.2003.'}, {'pmid': '21900636', 'type': 'RESULT', 'citation': 'Sacktor N, Miyahara S, Deng L, Evans S, Schifitto G, Cohen BA, Paul R, Robertson K, Jarocki B, Scarsi K, Coombs RW, Zink MC, Nath A, Smith E, Ellis RJ, Singer E, Weihe J, McCarthy S, Hosey L, Clifford DB; ACTG A5235 team. Minocycline treatment for HIV-associated cognitive impairment: results from a randomized trial. Neurology. 2011 Sep 20;77(12):1135-42. doi: 10.1212/WNL.0b013e31822f0412. Epub 2011 Sep 7.'}, {'pmid': '25377444', 'type': 'RESULT', 'citation': 'Sacktor N, Miyahara S, Evans S, Schifitto G, Cohen B, Haughey N, Drewes JL, Graham D, Zink MC, Anderson C, Nath A, Pardo CA, McCarthy S, Hosey L, Clifford D; ACTG A5235 team. Impact of minocycline on cerebrospinal fluid markers of oxidative stress, neuronal injury, and inflammation in HIV-seropositive individuals with cognitive impairment. J Neurovirol. 2014 Dec;20(6):620-6. doi: 10.1007/s13365-014-0292-0. Epub 2014 Nov 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effectiveness of minocycline, an antibiotic, in lessening the decreased mental function sometimes caused by anti-HIV drugs.', 'detailedDescription': 'Cognitive impairment, including disabling cognitive, behavioral, and social dysfunction, continues to be a major problem faced by HIV-infected people taking antiretroviral therapy (ART). Research is needed to develop treatment that can be given alongside ART to prevent or lessen cognitive impairment caused by ART. Minocycline, an antibiotic commonly used for the treatment of acne and rheumatoid arthritis, has demonstrated anti-inflammatory and neuroprotective properties in previous studies. This study will evaluate the effectiveness of 24-week therapy with minocycline in lessening the cognitive impairment of HIV infected adults taking ART.\n\nThis study will last at least 24 weeks and has two steps. Patients will be stratified by HIV viral load and their neurocognitive state at study screening. In Step I, patients will be randomly assigned to one of two groups. Group 1 participants will receive twice-daily minocycline for 24 weeks; Group 2 participants will receive placebo. At the end of Phase I, study participants will be offered to enter Step II; all participants in Step II will receive twice-daily minocycline for an additional 24 weeks.\n\nThere will be a total of 8 study visits: 5 visits for Step I (including the entry visit) and 3 visits for Step II. Medical history will occur at all visits. Blood collection will occur at all visits. Participants who have positive nonreactive rapid plasma regain (RPR) values at screening will have mandatory lumbar punctures; for those with negative serum RPR results lumbar punctures are optional. Participants who test positive for syphilis will also have a lumbar puncture at their discretion to determine if syphilis has affected the brain. A neurological exam, other neuropsychological, dementia, and depression scale assessments, and urine collection will occur at most visits. Patients will be asked to complete a questionnaire on daily living at study entry and Weeks 12 and 24. Patients who have a lumbar puncture at Week 24 will receive a phone call 2 to 5 days after the procedure to report any adverse effects. Some participants may also have an electrocardiogram (ECG) during the study. For participants not on atazanavir some procedures and sample collections are optional.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HIV infected\n* Currently on a stable ART regimen for at least 16 consecutive weeks prior to study entry. Participants whose regimens have changed with respect to dose or formulation are eligible, but patients who have changed to different drugs in the same class are not eligible. Participants taking atazanavir must also be taking ritonavir or a ritonavir-boosted drug to be eligible for this study. More information on this criterion can be found in the protocol.\n* Plan to stay on current ART regimen between study screening and Week 24\n* AIDS Dementia Scale (ADC) Stage greater than 0\n* Cognitive impairment, as evidenced by neuropsychological tests administered at screening\n* Progressive neurocognitive decline. More information on this criterion can be found in the protocol.\n* Estimated premorbid IQ of 70 or higher indicated by an age-corrected scaled score of 5 or higher on the vocabulary section of the Wechsler Adult Intelligence Scale Revised (WAIS-R) administered at study screening\n* Karnofsky performance score of 60 or higher\n* Ability to sit and stand for at least 2 hours and swallow medications with an 8-ounce glass of water\n* Willing to use acceptable methods of contraception\n* Willing to adhere to study schedule\n\nExclusion Criteria:\n\n* Current cancers. Patients with basal cell carcinoma, in situ carcinoma of the cervix, or Kaposi's sarcoma without evidence of visceral involvement or cancer not requiring systemic chemotherapy are not excluded.\n* Severe premorbid psychiatric illness, including schizophrenia and major depression, which, in the opinion of the investigator, may interfere with the study\n* Active symptomatic AIDS-defining opportunistic infection within 45 days prior to study entry\n* Previous or current confounding neurological disorders. More information on this criterion can be found in the protocol.\n* Central nervous system infections or cancers. More information on this criterion can be found in the protocol.\n* Systemic lupus\n* Thyroid disease diagnosed within 24 weeks of study entry\n* Active drug or alcohol abuse that, in the opinion of the investigator, may interfere with the study\n* Serious illness requiring systemic treatment or hospitalization. Patients who complete therapy or are clinically stable on therapy are not excluded.\n* Investigational agents within 45 days prior to study entry. Patients taking expanded access drugs or drugs used in an ACTG protocol for HIV treatment or for HIV-associated complications that are not prohibited by this protocol are not excluded.\n* History of allergy/sensitivity to minocycline or other tetracyclines and their formulations\n* Any esophageal or other condition that would interfere with a patient's ability to swallow study medication\n* Participation in a previous clinical drug research trial of HIV-associated cognitive impairment. Patients who have had an objective decline in performance as defined by the protocol are not excluded.\n* Any other clinically significant condition or laboratory abnormality that, in the opinion of the investigator, would interfere with the study\n* Certain medications\n* Certain abnormal laboratory values. Patients who test positive on nonreactive rapid plasma reagin tests (RPR)are not excluded.\n* Inability to undergo lumbar punctures\n* Breastfeeding"}, 'identificationModule': {'nctId': 'NCT00361257', 'briefTitle': 'Minocycline for the Treatment of Decreased Mental Function in HIV-Infected Adults', 'organization': {'class': 'NETWORK', 'fullName': 'Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections'}, 'officialTitle': 'Phase II, Randomized, Placebo-Controlled, Double-Blind Study of Minocycline in the Treatment of HIV-Associated Cognitive Impairment', 'orgStudyIdInfo': {'id': 'ACTG A5235'}, 'secondaryIdInfos': [{'id': '1U01AI068636', 'link': 'https://reporter.nih.gov/quickSearch/1U01AI068636', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Minocycline', 'description': '100 mg orally every 12 hours', 'interventionNames': ['Drug: Minocycline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2: Matching placebo', 'description': 'orally every 12 hours', 'interventionNames': ['Drug: Placebo (Tetracycline)']}], 'interventions': [{'name': 'Minocycline', 'type': 'DRUG', 'description': 'Tetracycline antibiotic, 100 mg taken orally every 12 hours', 'armGroupLabels': ['Arm 1: Minocycline']}, {'name': 'Placebo (Tetracycline)', 'type': 'DRUG', 'description': 'Tetracycline antibiotic placebo, orally every 12 hours', 'armGroupLabels': ['Arm 2: Matching placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA-David Geffen School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80262-3706', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Health Science Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Ponce de Leon Ctr. CRS', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University CRS', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21287-8106', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital, Division of Infectious Diseases', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hosp. CRS', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63108-2138', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Med Ctr, Dept of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': '1101 University of Rochester Medical Center, Division of Infectious Diseases', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina, AIDS Clinical Trials Unit', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '97209', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'The Research and Education Group - Portland CRS', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania, ACTU', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '23219', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth Univ. Medical Ctr. CRS', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Univ of Washington, Harborview Medical Ctr', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Ned Sacktor, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Neurology, Johns Hopkins Bayview Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'Neurologic AIDS Research Consortium (NARC)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}