Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2026-03-13 @ 10:16 AM
Study NCT ID:
NCT00850395
Status:
COMPLETED
Last Update Posted:
2012-11-07
First Post:
2009-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-Interventional Study Of Celsentri® In Treatment Experienced Patients With CCR5-Tropic HIV-Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077592', 'term': 'Maraviroc'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Designation of outcomes as primary and secondary was based on study team input as study did not specify primary or secondary outcome measures.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Maraviroc', 'description': 'Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.', 'otherNumAtRisk': 79, 'otherNumAffected': 4, 'seriousNumAtRisk': 79, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Ichthyosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': "Hodgkin's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc', 'description': 'Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.10', 'spread': '1.530', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3', 'unitOfMeasure': 'copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full Analysis Set (FAS) population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc', 'description': 'Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.15', 'spread': '1.579', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'unitOfMeasure': 'copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc', 'description': 'Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.95', 'spread': '1.571', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'unitOfMeasure': 'copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc', 'description': 'Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.31', 'spread': '162.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3', 'unitOfMeasure': 'cells/mcL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc', 'description': 'Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.88', 'spread': '168.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'unitOfMeasure': 'cells/mcL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc', 'description': 'Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.57', 'spread': '237.70', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'unitOfMeasure': 'cells/mcL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc', 'description': 'Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.'}], 'classes': [{'title': 'Category A', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Category B', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Category C', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3', 'description': 'Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc', 'description': 'Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.'}], 'classes': [{'title': 'Category A', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Category B', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Category C', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc', 'description': 'Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.'}], 'classes': [{'title': 'Category A', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Category B', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Category C', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc', 'description': 'Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.'}], 'classes': [{'title': 'Change at Month 6 (n=51)', 'categories': [{'measurements': [{'value': '-4.87', 'spread': '12.527', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 (n=79)', 'categories': [{'measurements': [{'value': '-2.14', 'spread': '11.728', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 6, 12', 'description': "SDM consists of the 20 items questionnaire, each item rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health). A positive change from baseline indicates a decline in a participant's quality of life over that period.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS population. 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n' signifies participants evaluable at specified time point. Missing values were imputed only for Month 12 as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Human Immunodeficiency Virus (HIV) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc', 'description': 'Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Response was defined as a HIV-1 RNA count of less than 50 copies/mL.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all participants who received at least one dose (including partial doses) of study medication.'}, {'type': 'SECONDARY', 'title': "Physician's Assessment of Efficacy", 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc', 'description': 'Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.'}], 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Very Good', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Fair', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Number of participants with each grade of efficacy as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all participants who received at least one dose (including partial doses) of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Taking Concomitant Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc', 'description': 'Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.'}], 'classes': [{'title': 'ABC, FTC/TDF (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ABC, FTC/TDF (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ABC/LAM (Month 12)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'ABC/LAM (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'ABC/LAM, DRV, RAL (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ABC/LAM, DRV, RAL (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ABC/LAM, RAL (Month 12)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'ABC/LAM, RAL (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'ABC/LAM, RAL, TDF (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ABC/LAM, RAL, TDF (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATV (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATV (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATV, FTC/TDF (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATV, FTC/TDF (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATV, FTC/TDF, RTV (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATV, FTC/TDF, RTV (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATV, LAM, RAL, RTV (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATV, LAM, RAL, RTV (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ATV, RAL (Month 12)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'ATV, RAL (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'ATV, RAL, RTV (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATV, RAL, RTV (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATV, RTV (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATV, RTV (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'DRV, FTC/TDF (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'DRV, FTC/TDF (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'DRV, FTC/TDF, ETR (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'DRV, FTC/TDF, ETR (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'DRV, FTC/TDF, RTV (Month 12)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'DRV, FTC/TDF, RTV (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'DRV, ETV, ETR, RTV (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'DRV, ETV, ETR, RTV (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'DRV, LAM, RAL (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'DRV, LAM, RAL (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'DRV, LAM, RAL, RTV (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'DRV, LAM, RAL, RTV (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'DRV, LAM, TDF (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'DRV, LAM, TDF (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'DRV, NVP, RAL, RTV (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'DRV, NVP, RAL, RTV (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'DRV, RAL, RTV (Month 12)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'DRV, RAL, RTV (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'DRV, RTV (Month 12)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'DRV, RTV (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'DRV, RTV, TZV (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'DRV, RTV, TZV (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'FTC/TDF (Month 12)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'FTC/TDF (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'FTC/TDF, Kaletra (Month 12)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'FTC/TDF, Kaletra (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'FTC/TDF, Kaletra, RAL (Month 12)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'FTC/TDF, Kaletra, RAL (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'FTC/TDF, Kaletra, SQV (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'FTC/TDF, Kaletra, SQV (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'FTC/TDF, RAL (Month 12)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'FTC/TDF, RAL (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'FTC/TDF, RAL, SQV (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'FTC/TDF, RAL, SQV (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ETR, RAL, RTV (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ETR, RAL, RTV (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Kaletra (Month 12)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Kaletra (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'LAM, RAL, TDF, ZDV (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'LAM, RAL, TDF, ZDV (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'RAL (Month 12)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'RAL (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'RAL, TDF (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'RAL, TDF (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'RAL, ZDV W/LAM (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'RAL, ZDV W/LAM (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'TDF, TZV (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'TDF, TZV (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'TDF, ZDV (Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'TDF, ZDV (Baseline, Month 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 12', 'description': 'Participants taking HIV/AIDS concomitant medication at Month 12, at Baseline and Month 12 were reported. It included Emtricitabine/tenofovir disoproxil fumarate(FTC/TDF),Raltegravir(RAL), Ritonavir (RTV), Darunavir(DRV), Kaletra, Atazanavir sulfate(ATV), Abacavir sulfate/lamivudine(ABC/LAM), Tenofovir disoproxil fumarate(TDF), Etravirine(ETR), Lamivudine (LAM), Zidovudine W/lamivudine(ZDV W/LAM), Nevirapine(NVP), Saquinavir mesilate(SQV), Trizivir(TZV), Zidovudine(ZDV), Abacavir sulfate(ABC), Emtricitabine(FTC),Entecavir(ETV).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all participants who received at least one dose (including partial doses) of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Maraviroc', 'description': 'Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Insufficient clinical response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Maraviroc', 'description': 'Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.1', 'spread': '11.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA)', 'classes': [{'categories': [{'measurements': [{'value': '3.01', 'spread': '1.599', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Number of participants evaluable for this measure=78.', 'unitOfMeasure': 'copies/milliliter (copies/mL)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cluster of Differentiation 4 (CD4+) Cell Counts', 'classes': [{'categories': [{'measurements': [{'value': '458.8', 'spread': '250.14', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells/microliter (cells/mcL)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Participants With Centers for Disease Control and Prevention (CDC) Classification', 'classes': [{'title': 'Category A', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}, {'title': 'Category B', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Category C', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).', 'unitOfMeasure': 'participants'}, {'title': 'Acquired Immune Deficiency Syndrome Clinical Trials Group Symptom Distress Module(SDM) Overall Score', 'classes': [{'categories': [{'measurements': [{'value': '17.37', 'spread': '14.026', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "SDM: 20 items questionnaire, each item rated from 0 to 4, 0=complete absence of symptom and 4=very bothersome symptom. Overall score: sum of scores for each of 20 items of questionnaire, with 0=best health and 80=worst health. A positive change from baseline indicates decline in participant's quality of life. Number of participants evaluable=55.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-05', 'studyFirstSubmitDate': '2009-02-23', 'resultsFirstSubmitDate': '2012-09-11', 'studyFirstSubmitQcDate': '2009-02-24', 'lastUpdatePostDateStruct': {'date': '2012-11-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-11', 'studyFirstPostDateStruct': {'date': '2009-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3', 'timeFrame': 'Baseline, Month 3'}, {'measure': 'Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6', 'timeFrame': 'Baseline, Month 6'}, {'measure': 'Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12', 'timeFrame': 'Baseline, Month 12'}, {'measure': 'Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3', 'timeFrame': 'Baseline, Month 3'}, {'measure': 'Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6', 'timeFrame': 'Baseline, Month 6'}, {'measure': 'Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12', 'timeFrame': 'Baseline, Month 12'}, {'measure': 'Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3', 'timeFrame': 'Month 3', 'description': 'Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).'}, {'measure': 'Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6', 'timeFrame': 'Month 6', 'description': 'Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).'}, {'measure': 'Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12', 'timeFrame': 'Month 12', 'description': 'Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12', 'timeFrame': 'Baseline, Months 6, 12', 'description': "SDM consists of the 20 items questionnaire, each item rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health). A positive change from baseline indicates a decline in a participant's quality of life over that period."}, {'measure': 'Number of Participants With Human Immunodeficiency Virus (HIV) Response', 'timeFrame': 'Month 12', 'description': 'Response was defined as a HIV-1 RNA count of less than 50 copies/mL.'}, {'measure': "Physician's Assessment of Efficacy", 'timeFrame': 'Month 12', 'description': 'Number of participants with each grade of efficacy as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.'}, {'measure': 'Number of Participants Taking Concomitant Therapy', 'timeFrame': 'Baseline, Month 12', 'description': 'Participants taking HIV/AIDS concomitant medication at Month 12, at Baseline and Month 12 were reported. It included Emtricitabine/tenofovir disoproxil fumarate(FTC/TDF),Raltegravir(RAL), Ritonavir (RTV), Darunavir(DRV), Kaletra, Atazanavir sulfate(ATV), Abacavir sulfate/lamivudine(ABC/LAM), Tenofovir disoproxil fumarate(TDF), Etravirine(ETR), Lamivudine (LAM), Zidovudine W/lamivudine(ZDV W/LAM), Nevirapine(NVP), Saquinavir mesilate(SQV), Trizivir(TZV), Zidovudine(ZDV), Abacavir sulfate(ABC), Emtricitabine(FTC),Entecavir(ETV).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV-1', 'non-interventional', 'CCR-5 tropic virus', 'therapy experienced patients'], 'conditions': ['HIV-1']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001070&StudyName=Non-Interventional%20Study%20Of%20Celsentri%AE%20In%20Treatment%20Experienced%20Patients%20With%20CCR5-Tropic%20HIV-Infection', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Aim of the study is to gain more knowledge about efficacy of CELSENTRI® in daily clinical practice and obtain information about the quality of life of patients using CELSENTRI®.', 'detailedDescription': 'Non interventional study, inclusion and exclusion criteria defined by the labelling of Celsentri (Maraviroc).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV-1 infected, therapy-experienced patients, CCR5-tropic virus,', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHIV-1 infection. CCR-5 tropic virus. Therapy experienced patient,\n\nExclusion Criteria:\n\nX4 or D/M tropic virus. Therapy-naive patients.'}, 'identificationModule': {'nctId': 'NCT00850395', 'briefTitle': 'Non-Interventional Study Of Celsentri® In Treatment Experienced Patients With CCR5-Tropic HIV-Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'Non-Interventional Study Of Celsentri® In Treatment Experienced Patients Infected With CCR5 Tropic HIV-1', 'orgStudyIdInfo': {'id': 'A4001070'}, 'secondaryIdInfos': [{'id': 'CELTROP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Non-Interventional', 'interventionNames': ['Drug: maraviroc']}], 'interventions': [{'name': 'maraviroc', 'type': 'DRUG', 'otherNames': ['Selzentry, Celsentri'], 'description': 'No intervention; any procedure at the discretion of the treating physician, in line with the SmPC', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}