Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT00830804
Status:
COMPLETED
Last Update Posted:
2018-11-08
First Post:
2009-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Effectiveness of Raltegravir Plus Darunavir/Ritonavir in Treatment-Naive HIV-Infected Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068898', 'term': 'Raltegravir Potassium'}, {'id': 'D000069454', 'term': 'Darunavir'}, {'id': 'D019438', 'term': 'Ritonavir'}], 'ancestors': [{'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, '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': 'This is a single-arm study.'}}, 'adverseEventsModule': {'timeFrame': 'From start of study treatment to week 52', 'description': 'Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \\>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.', 'eventGroups': [{'id': 'EG000', 'title': 'RAL+DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks', 'otherNumAtRisk': 112, 'otherNumAffected': 78, 'seriousNumAtRisk': 112, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood cholesterol', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 45}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood glucose abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Low density lipoprotein abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 34}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Jejunal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Substance abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Henoch-Schonlein purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RAL+DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.24'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of study treatment to week 24', 'description': "Virologic failure is defined as: at week 12, confirmed plasma HIV-1 RNA \\>= 1000 copies/ml or confirmed rebound from the week 4 value by \\>0.5 log10 copies/ml (for subjects with week 4 value \\<= 50 copies/ml, confirmed rebound to \\>50 copies/ml); at week 24 or later, confirmed value \\> 50 copies/ml. Viral load confirmation was scheduled 7-35 days after initial virologic failure. The proportion was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.", 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started study treatment were included. The intent-to-treat approach was used, ignoring whether a participant was on or off treatment at the time of HIV-1 RNA measurement and censoring follow-up if a participant was lost-to-follow-up without previously meeting the definition of virologic failure.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RAL+DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '0.29'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of study treatment to Week 24', 'description': "The proportion of participants with virologic failure (see primary outcome measure for definition) and/or premature treatment discontinuation/modification and/or death was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.", 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started study treatment were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Plasma HIV-1 RNA From Baseline to Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RAL+DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.67', 'groupId': 'OG000', 'lowerLimit': '-1.93', 'upperLimit': '-1.42'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and week 1', 'description': 'Results report the week 1 change from baseline (week 1 - baseline) in HIV-1 RNA. Baseline HIV-1 RNA was computed as the mean of the log10 HIV-1 RNA values at pre-entry and study entry.', 'unitOfMeasure': 'log10 copies/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyis was based on an intent-to-treat approach, ignoring whether a participant was on or off study treatment at the time the sample for HIV-1 RNA was obtained.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RAL+DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks'}], 'classes': [{'title': 'With HIV-1 RNA < 50 copies/ml', 'categories': [{'measurements': [{'value': '0.79', 'groupId': 'OG000', 'lowerLimit': '0.70', 'upperLimit': '0.86'}]}]}, {'title': 'With HIV-1 RNA < 200 copies/ml', 'categories': [{'measurements': [{'value': '0.93', 'groupId': 'OG000', 'lowerLimit': '0.87', 'upperLimit': '0.97'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of study treatment to week 24', 'description': 'Results report the percentage of participants with plasma HIV-1 RNA \\< 50 copies/ml or \\<200 copies/ml at week 24.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started study treatment were included. An intent-to-treat approach was used ignoring participants who were off-study or with missing HIV-1 RNA at week 24.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RAL+DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks'}], 'classes': [{'title': 'With HIV-1 RNA < 50 copies/ml', 'categories': [{'measurements': [{'value': '0.71', 'groupId': 'OG000', 'lowerLimit': '0.61', 'upperLimit': '0.79'}]}]}, {'title': 'With HIV-1 RNA < 200 copies/ml', 'categories': [{'measurements': [{'value': '0.86', 'groupId': 'OG000', 'lowerLimit': '0.78', 'upperLimit': '0.92'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of study treatment to week 48', 'description': 'Results report the percentage of participants with plasma HIV-1 RNA \\<50 copies/ml or \\<200 copies/ml at week 48.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started study treatment were included. An intent-to-treat approach was used ignoring participants who were off study treatment or with missing HIV-1 RNA at week 48.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RAL+DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000', 'lowerLimit': '0.13', 'upperLimit': '0.28'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of study treatment to week 52', 'description': 'Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Results report the percentage of participants who had grade 3 or higher events, or events of any grade which led to a permanent change or discontinuation of study treatment, which occurred any time from start of treatment to end of treatment.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started study treatment were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pretreatment Drug Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RAL + DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks'}], 'classes': [{'title': 'With NNRTI mutations only', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'With NRTI mutations only', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'With Both NNRTI and NRTI mutations', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'With PI mutations only', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'With PI, NNRTI and NRTI mutations', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'No Resistance Detected', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At screening', 'description': "Results report the number of participants who had resistance to non-nucleoside reverse transciptase inhibitors (NNRTI), nucleoside reverse transciptase inhibitors (NRTI) and protease inbitors (PI) based on genotypic resistance testing done prior to participant's entry into the study. Participants are classified into one (and only one category) based on the maximum number of drug class resistance seen for the participant.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started study treatment were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Integrase Drug Resistance at Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RAL+DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 12 weeks after starting study treatment to week 52', 'description': 'Results report the number of participants who had integrase resistance mutation(s) detected at the time of virologic failure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those participants who had virologic failure (see primary outcome measure for definition) and who had successful integrase genotyping at failure were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Protease Drug Resistance at Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RAL+DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 12 weeks after starting study treatment to week 52', 'description': 'Results report the number of participants who had protease resistance mutation(s) detected at the time of virologic failure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those participants who had virologic failure (see primary outcome measure for definition) and who had successful protease genotyping at failure were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Perfect Overall Adherence by Self Report', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RAL + DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From one week after starting study treatment to week 52', 'description': 'At each study visit, adherence was measured in terms of the number of missed doses each participant had over a 4-day recall for each drug. Adherence for all study visit weeks were combined for an overall measure of adherence. Participants who had zero missed doses on all weeks in all drugs while on study were classified as having an overall "perfect" adherence.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started study treatment were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RAL + DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks'}], 'classes': [{'title': 'Fasting Total Cholesterol', 'categories': [{'measurements': [{'value': '31.5', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '46'}]}]}, {'title': 'Fasting High-density Lipoprotein', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '15'}]}]}, {'title': 'Fasting Triglyceride', 'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000', 'lowerLimit': '-6', 'upperLimit': '64'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study treatment through week 24', 'description': 'Results report the week 24 change from week 0 (week 24 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those participants who started study treatment and who had fasting lipid measurements at week 24 and week 0 were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Low-density Lipoprotein at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RAL + DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '36'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study treatment through week 24', 'description': 'Results report the week 24 change from week 0 (week 24 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those participants who started study treatment and who had fasting lipid measurements at week 24 and week 0 were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RAL + DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks'}], 'classes': [{'title': 'Fasting Total Cholesterol', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '59'}]}]}, {'title': 'Fasting High-density Lipoprotein', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '17'}]}]}, {'title': 'Fasting Triglyceride', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '-31', 'upperLimit': '81'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study treatment through week 48', 'description': 'Results report the week 48 change from week 0 (week 48 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those participants who started study treatment and who had fasting lipid measurements at week 48 and week 0 were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Low-density Lipoprotein at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RAL + DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '33'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study treatment through week 48', 'description': 'Results report the week 48 change from week 0 (week 48 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those participants who started study treatment and who had fasting lipid measurements at week 48 and week 0 were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in CD4 Count at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RAL + DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000', 'lowerLimit': '114', 'upperLimit': '318'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study treatment through week 48', 'description': 'Results report the week 48 change from baseline (week 48 - baseline) in CD4 count. Baseline CD4 count was computed as the mean of CD4 count values at pre-entry and study entry.', 'unitOfMeasure': 'cells/mm3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those participants who started study treatment and who have values at baseline and at week 48 were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Plasma Trough Concentration of Raltegravir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RAL+DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': '250'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study treatment to week 52', 'description': 'Plasma trough concentrations (ng/ml) of Raltegravir (RAL) below the detection limit (10 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 9-15 hours after the last RAL dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who started study treatment and who have at least one RAL plasma trough concentration obtained within 9-15 hours after the last RAL dose were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Plasma Trough Concentration of Darunavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RAL+DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1218', 'groupId': 'OG000', 'lowerLimit': '789', 'upperLimit': '1809'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study treatment to week 52', 'description': 'Plasma trough concentrations (ng/ml) of Darunavir (DRV) below the detection limit (50 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 20-28 hours after the last DRV dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who started study treatment and who have at least one DRV plasma trough concentration obtained within 20-28 hours after the last DRV dose were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RAL + DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '113 subjects enrolled. One subject never started study treatment and was excluded in all analysis.', 'groupId': 'FG000', 'numSubjects': '112'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Unable to get to clinic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Consent withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Unwilling to adhere to study requirement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Study participants were recruited from 22 U.S. sites from April 2009 to August 2009.', 'preAssignmentDetails': 'Study participants were HIV-1-infected, antiretroviral(ARV)-naive men and women, 18 years and older with plasma HIV-1 RNA \\>= 5000 copies/ml. One enrolled participant never started study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'RAL+DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36', 'spread': '11', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '66'}]}]}], 'paramType': 'MEDIAN', 'description': 'Age (in years) of participants at study entry', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '18-29', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}, {'title': '30-39', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}, {'title': '40-49', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}, {'title': '50-59', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': '60-69', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Age (in years) of participants at study entry', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '98', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-11', 'studyFirstSubmitDate': '2009-01-26', 'resultsFirstSubmitDate': '2011-09-07', 'studyFirstSubmitQcDate': '2009-01-27', 'lastUpdatePostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-09-07', 'studyFirstPostDateStruct': {'date': '2009-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24', 'timeFrame': 'From start of study treatment to week 24', 'description': "Virologic failure is defined as: at week 12, confirmed plasma HIV-1 RNA \\>= 1000 copies/ml or confirmed rebound from the week 4 value by \\>0.5 log10 copies/ml (for subjects with week 4 value \\<= 50 copies/ml, confirmed rebound to \\>50 copies/ml); at week 24 or later, confirmed value \\> 50 copies/ml. Viral load confirmation was scheduled 7-35 days after initial virologic failure. The proportion was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval."}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24', 'timeFrame': 'From start of study treatment to Week 24', 'description': "The proportion of participants with virologic failure (see primary outcome measure for definition) and/or premature treatment discontinuation/modification and/or death was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval."}, {'measure': 'Change in Plasma HIV-1 RNA From Baseline to Week 1', 'timeFrame': 'Baseline and week 1', 'description': 'Results report the week 1 change from baseline (week 1 - baseline) in HIV-1 RNA. Baseline HIV-1 RNA was computed as the mean of the log10 HIV-1 RNA values at pre-entry and study entry.'}, {'measure': 'Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24', 'timeFrame': 'From start of study treatment to week 24', 'description': 'Results report the percentage of participants with plasma HIV-1 RNA \\< 50 copies/ml or \\<200 copies/ml at week 24.'}, {'measure': 'Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48', 'timeFrame': 'From start of study treatment to week 48', 'description': 'Results report the percentage of participants with plasma HIV-1 RNA \\<50 copies/ml or \\<200 copies/ml at week 48.'}, {'measure': 'Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment', 'timeFrame': 'From start of study treatment to week 52', 'description': 'Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Results report the percentage of participants who had grade 3 or higher events, or events of any grade which led to a permanent change or discontinuation of study treatment, which occurred any time from start of treatment to end of treatment.'}, {'measure': 'Number of Participants With Pretreatment Drug Resistance', 'timeFrame': 'At screening', 'description': "Results report the number of participants who had resistance to non-nucleoside reverse transciptase inhibitors (NNRTI), nucleoside reverse transciptase inhibitors (NRTI) and protease inbitors (PI) based on genotypic resistance testing done prior to participant's entry into the study. Participants are classified into one (and only one category) based on the maximum number of drug class resistance seen for the participant."}, {'measure': 'Number of Participants With Integrase Drug Resistance at Virologic Failure', 'timeFrame': 'From 12 weeks after starting study treatment to week 52', 'description': 'Results report the number of participants who had integrase resistance mutation(s) detected at the time of virologic failure.'}, {'measure': 'Number of Participants With Protease Drug Resistance at Virologic Failure', 'timeFrame': 'From 12 weeks after starting study treatment to week 52', 'description': 'Results report the number of participants who had protease resistance mutation(s) detected at the time of virologic failure.'}, {'measure': 'Number of Participants With Perfect Overall Adherence by Self Report', 'timeFrame': 'From one week after starting study treatment to week 52', 'description': 'At each study visit, adherence was measured in terms of the number of missed doses each participant had over a 4-day recall for each drug. Adherence for all study visit weeks were combined for an overall measure of adherence. Participants who had zero missed doses on all weeks in all drugs while on study were classified as having an overall "perfect" adherence.'}, {'measure': 'Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24', 'timeFrame': 'From start of study treatment through week 24', 'description': 'Results report the week 24 change from week 0 (week 24 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.'}, {'measure': 'Change in Fasting Low-density Lipoprotein at Week 24', 'timeFrame': 'From start of study treatment through week 24', 'description': 'Results report the week 24 change from week 0 (week 24 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.'}, {'measure': 'Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48', 'timeFrame': 'From start of study treatment through week 48', 'description': 'Results report the week 48 change from week 0 (week 48 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.'}, {'measure': 'Change in Fasting Low-density Lipoprotein at Week 48', 'timeFrame': 'From start of study treatment through week 48', 'description': 'Results report the week 48 change from week 0 (week 48 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.'}, {'measure': 'Change in CD4 Count at Week 48', 'timeFrame': 'From start of study treatment through week 48', 'description': 'Results report the week 48 change from baseline (week 48 - baseline) in CD4 count. Baseline CD4 count was computed as the mean of CD4 count values at pre-entry and study entry.'}, {'measure': 'Plasma Trough Concentration of Raltegravir', 'timeFrame': 'From start of study treatment to week 52', 'description': 'Plasma trough concentrations (ng/ml) of Raltegravir (RAL) below the detection limit (10 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 9-15 hours after the last RAL dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.'}, {'measure': 'Plasma Trough Concentration of Darunavir', 'timeFrame': 'From start of study treatment to week 52', 'description': 'Plasma trough concentrations (ng/ml) of Darunavir (DRV) below the detection limit (50 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 20-28 hours after the last DRV dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Treatment Naive'], 'conditions': ['HIV-1 Infections']}, 'referencesModule': {'references': [{'pmid': '19155770', 'type': 'BACKGROUND', 'citation': 'Capetti AF, Piconi S, Landonio S, Rizzardini G, Perno CF. Is dual therapy with raltegravir and protease inhibitors a feasible option in rescue strategy in HIV-1 infection? J Acquir Immune Defic Syndr. 2009 Feb 1;50(2):233-4. doi: 10.1097/QAI.0b013e31818c7e8e. No abstract available.'}, {'pmid': '19149996', 'type': 'BACKGROUND', 'citation': 'Long MC, King JR, Acosta EP. Pharmacologic aspects of new antiretroviral drugs. Curr HIV/AIDS Rep. 2009 Feb;6(1):43-50. doi: 10.1007/s11904-009-0007-y.'}, {'pmid': '19131522', 'type': 'BACKGROUND', 'citation': 'Vermeir M, Lachau-Durand S, Mannens G, Cuyckens F, van Hoof B, Raoof A. Absorption, metabolism, and excretion of darunavir, a new protease inhibitor, administered alone and with low-dose ritonavir in healthy subjects. Drug Metab Dispos. 2009 Apr;37(4):809-20. doi: 10.1124/dmd.108.024109. Epub 2009 Jan 8.'}, {'pmid': '21857490', 'type': 'DERIVED', 'citation': 'Taiwo B, Zheng L, Gallien S, Matining RM, Kuritzkes DR, Wilson CC, Berzins BI, Acosta EP, Bastow B, Kim PS, Eron JJ Jr; ACTG A5262 Team. Efficacy of a nucleoside-sparing regimen of darunavir/ritonavir plus raltegravir in treatment-naive HIV-1-infected patients (ACTG A5262). AIDS. 2011 Nov 13;25(17):2113-22. doi: 10.1097/QAD.0b013e32834bbaa9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effectiveness and safety of an antiretroviral therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as first-line therapy in treatment-naïve participants.', 'detailedDescription': 'Despite the remarkable strides made in the treatment of HIV-1-infected persons over the last decade, current first-line ART regimens are imperfect. The ideal combination, unlike some current first-line options, would have uncompromised efficacy in the presence of transmitted drug-resistant variants. The primary purpose of this study is to estimate the cumulative proportion of ART-naive participants experiencing virologic failure at or prior to week 24 after initiating raltegravir (RAL) plus darunavir/ritonavir (DRV/RTV).\n\nThe study will last 52 weeks. All participants will follow the same treatment schedule and take RAL plus DRV/RTV orally daily for the duration of the trial.\n\nAfter entry, all participants will have scheduled visits at weeks 1, 4, 12, 24, 36, 48, and 52. Medical/medication history, blood and urine collection, and liver function tests will occur at screening. A targeted physical exam and concomitant medications history will occur at all study visits. Blood and urine collection and liver function tests will occur at most study visits. For females, a pregnancy test will occur at screening and study entry.\n\nRAL and DRV were provided by the study. RTV was not provided by the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1-infected\n* Plasma HIV-1 RNA of at least 5,000 copies/mL within 90 days prior to study entry\n* HIV genotype (for reverse transcriptase and protease) performed at any time prior to study entry. More information on this criterion can be found in the protocol.\n* ARV drug-naive. More information on this criterion can be found in the protocol.\n* Negative result from a hepatitis B surface antigen test performed within 90 days prior to study entry\n* Agree to use one form of medically-accepted contraceptive throughout the study and for 60 days after stopping study treatment. More information on this criterion can be found in the protocol.\n\nExclusion Criteria:\n\n* Serious illness requiring systemic treatment and/or hospitalization for at least 7 days prior to study. More information on this criterion can be found in the protocol.\n* Screening HIV genotype obtained any time prior to study entry with more than one DRV resistance-associated mutation \\[RAM\\] (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, I84V, and L89V) or L76V alone\n* Known major integrase inhibitor RAM(s), including N155H, Q148H/R/K, Y143C/R, and G140S\n* Severe renal insufficiency requiring hemodialysis or peritoneal dialysis\n* Treatment with immunomodulators within 30 days prior to study entry. More information on this criterion can be found in the protocol.\n* Current medications that are prohibited with any study medications. More information on this criterion can be found in the protocol.\n* Known allergy/sensitivity to study drugs or their formulations. A history of sulfa allergy is not an exclusion.\n* Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with the study.\n* Certain abnormal laboratory results. More information on this criterion can be found in the protocol.\n* Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT00830804', 'briefTitle': 'Safety and Effectiveness of Raltegravir Plus Darunavir/Ritonavir in Treatment-Naive HIV-Infected Adults', 'organization': {'class': 'NETWORK', 'fullName': 'Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections'}, 'officialTitle': 'A Pilot Efficacy and Safety Trial of Raltegravir Plus Darunavir/Ritonavir for Treatment-Naive HIV-1-Infected Subjects', 'orgStudyIdInfo': {'id': 'ACTG A5262'}, 'secondaryIdInfos': [{'id': '1U01AI068636', 'link': 'https://reporter.nih.gov/quickSearch/1U01AI068636', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RAL + DRV/RTV', 'description': 'Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks', 'interventionNames': ['Drug: Raltegravir', 'Drug: Darunavir/Ritonavir']}], 'interventions': [{'name': 'Raltegravir', 'type': 'DRUG', 'otherNames': ['RAL'], 'description': '400 mg tablet taken orally twice daily', 'armGroupLabels': ['RAL + DRV/RTV']}, {'name': 'Darunavir/Ritonavir', 'type': 'DRUG', 'otherNames': ['DRV/RTV'], 'description': '800 mg Darunavir/100 mg Ritonavir tablet taken orally once daily', 'armGroupLabels': ['RAL + DRV/RTV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'AlabamaTherapeutics CRS', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford CRS', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Ucsd, Avrc Crs', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Ucsf Aids Crs', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital CRS', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University CRS', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University CRS', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Med Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hosp. ACTG CRS", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington U CRS', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '14604', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'AIDS Community Health Ctr. ACTG CRS', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Unc Aids Crs', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Univ. Med. Ctr. Adult CRS', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45267-0405', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Univ. of Cincinnati CRS', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case CRS', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth CRS', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State Univ. AIDS CRS', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hosp. of the Univ. of Pennsylvania CRS', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh CTU', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Therapeutics CRS', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston AIDS Research Team', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Joseph J. Eron, Jr., MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, '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'}], 'responsibleParty': {'type': 'SPONSOR'}}}}