Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-01-01 @ 8:40 AM
Study NCT ID:
NCT00384904
Status:
COMPLETED
Last Update Posted:
2010-02-05
First Post:
2006-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Interaction Study of Famotidine and Atazanavir With Ritonavir in HIV-Infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C000718687', 'term': 'atazanavir, ritonavir drug combination'}, {'id': 'D000069446', 'term': 'Atazanavir Sulfate'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'D015738', 'term': 'Famotidine'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'dispFirstSubmitDate': '2010-02-03', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-03', 'studyFirstSubmitDate': '2006-10-03', 'dispFirstSubmitQcDate': '2010-02-03', 'studyFirstSubmitQcDate': '2006-10-05', 'dispFirstPostDateStruct': {'date': '2010-02-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2010-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atazanavir plasma drug concentrations', 'timeFrame': 'on days 10, 11, 17, 18, 24 and 25'}], 'secondaryOutcomes': [{'measure': 'Ritonavir plasma drug concentrations', 'timeFrame': 'on days 10, 11, 17, 18, 24 and 25'}, {'measure': 'Safety measures: Physical examinations'}, {'measure': 'ECGs', 'timeFrame': 'entry and discharge'}, {'measure': 'laboratory tests including, liver and renal function', 'timeFrame': 'entry, discharge and days 11, 18'}, {'measure': 'CD4 count', 'timeFrame': 'discharge'}, {'measure': 'HIV viral load', 'timeFrame': 'entry and discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical research study is to assess the effect of Famotidine given twice daily on Atazanavir administered with Ritonavir in HIV-Infected subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-infected male and female subjects between the ages of 18 to 65 years old with a BMI 18 to 35 kg/m²\n* Prior to enrollment subjects must be currently receiving Atazanavir/Ritonavir plus at least 2 NRTIs, must have plasma HIV RNA \\<400 copies/mL and have CD4 count \\>200 cells/mm³'}, 'identificationModule': {'nctId': 'NCT00384904', 'briefTitle': 'Drug Interaction Study of Famotidine and Atazanavir With Ritonavir in HIV-Infected Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Famotidine With or Without Tenofovir on the Pharmacokinetics of Atazanavir When Given With Ritonavir in HIV-Infected Subjects', 'orgStudyIdInfo': {'id': 'AI424-328'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'A1', 'interventionNames': ['Drug: Atazanavir/Ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'A2', 'interventionNames': ['Drug: Atazanavir/Ritonavir + Famotidine']}, {'type': 'EXPERIMENTAL', 'label': 'A3', 'interventionNames': ['Drug: Atazanavir/Ritonavir + Famotidine']}, {'type': 'NO_INTERVENTION', 'label': 'B1', 'interventionNames': ['Drug: Atazanavir/Ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'B2', 'interventionNames': ['Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine']}, {'type': 'EXPERIMENTAL', 'label': 'B3', 'interventionNames': ['Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine']}], 'interventions': [{'name': 'Atazanavir/Ritonavir', 'type': 'DRUG', 'otherNames': ['Reyataz'], 'description': 'Capsules/capsules, Oral, 300/100 mg, Once daily, 10 days.', 'armGroupLabels': ['A1']}, {'name': 'Atazanavir/Ritonavir + Famotidine', 'type': 'DRUG', 'otherNames': ['Reyataz'], 'description': 'Capsules/capsules + Tablets, Oral, 300/100 mg + 40 mg, Once daily + Twice daily, 7 days.', 'armGroupLabels': ['A2']}, {'name': 'Atazanavir/Ritonavir + Famotidine', 'type': 'DRUG', 'otherNames': ['Reyataz'], 'description': 'Capsules/capsules + Tablets, Oral, 300/100 mg + 20 mg, Once daily + Twice daily, 7 days.', 'armGroupLabels': ['A3']}, {'name': 'Atazanavir/Ritonavir', 'type': 'DRUG', 'otherNames': ['Reyataz'], 'description': 'Capsules/capsules + Tablets, Oral, 300/100 mg, Once daily, 10 days.', 'armGroupLabels': ['B1']}, {'name': 'Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine', 'type': 'DRUG', 'otherNames': ['Reyataz'], 'description': 'Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 40 mg, Once daily + Twice daily, 7 days.', 'armGroupLabels': ['B2']}, {'name': 'Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine', 'type': 'DRUG', 'otherNames': ['Reyataz'], 'description': 'Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 20 mg, Once daily + Twice daily, 7 days.', 'armGroupLabels': ['B3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08043', 'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Garden State Infectious Disease Associates, Pa', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Unc Center For Aids Research', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': 'SW10 9TH', 'city': 'London', 'state': 'Greater London', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}