Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 8:25 AM
Study NCT ID:
NCT00036634
Status:
COMPLETED
Last Update Posted:
2014-01-15
First Post:
2002-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive 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': 'D000068698', 'term': 'Tenofovir'}, {'id': 'C442442', 'term': 'tenofovir alafenamide'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2003-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-13', 'studyFirstSubmitDate': '2002-05-13', 'studyFirstSubmitQcDate': '2002-05-13', 'lastUpdatePostDateStruct': {'date': '2014-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-weighted average change from baseline through Week 2 (DAVG2) for HIV-1 RNA (log10 copies/mL)', 'timeFrame': 'Baseline to Week 2', 'description': 'DAVG2 was defined as the time-weighted average between baseline value through the last available value up to week 2 minus the baseline value.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in HIV-1 RNA (log10 copies/mL)', 'timeFrame': 'Baseline to Week 2'}, {'measure': 'Change from baseline in CD4 cell count (cells/mm3)', 'timeFrame': 'Baseline to Week 2'}]}, 'conditionsModule': {'keywords': ['treatment naive'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir DF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* HIV-1 RNA levels greater than or equal to 30,000 copies/mL\n* CD4 count greater than or equal to 200 cells/mm3\n* Serum creatinine \\<1.5 mg/dl\n* Hepatic transaminases less than or equal to 2.5 times the upper limit of normal\n* Total bilirubin less than or equal to 1.5 mg/dL\n* Adequate hematologic function\n* Serum amylase less than or equal to 1.5 times the upper limit of normal\n* Serum phosphate greater than or equal to 2.2 mg/dL\n* Not pregnant\n\nExclusion Criteria\n\n* Prior treatment with antiretroviral therapy\n* Immunization within 30 days of study entry\n* A new AIDS defining condition within 30 days of study entry\n* Receiving nephrotoxic agents, probenecid, chemotherapeutic agents, corticosteroids, interleukin-2'}, 'identificationModule': {'nctId': 'NCT00036634', 'briefTitle': 'A Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 1/2, Randomized, Double-Blind, Active Controlled, Dose Escalation Study of the Safety, Tolerance, Pharmacokinetic,, and Antiviral Activity of GS-7340-02 in Antiretroviral-Naive Patients Who Are Chronically Infected With HIV-1', 'orgStudyIdInfo': {'id': 'GS-120-1101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tenofovir DF', 'description': 'Participants received tenofovir DF 300 mg for 14 days', 'interventionNames': ['Drug: Tenofovir DF']}, {'type': 'EXPERIMENTAL', 'label': 'Tenofovir alafenamide 50 mg', 'description': 'Participants received tenofovir alafenamide 50 mg for 14 days', 'interventionNames': ['Drug: Tenofovir alafenamide']}, {'type': 'EXPERIMENTAL', 'label': 'Tenofovir alafenamide 150 mg', 'description': 'Participants received tenofovir alafenamide 150 mg for 14 days', 'interventionNames': ['Drug: Tenofovir alafenamide']}], 'interventions': [{'name': 'Tenofovir DF', 'type': 'DRUG', 'otherNames': ['Viread®'], 'description': 'Tenofovir DF tablet administered orally once daily', 'armGroupLabels': ['Tenofovir DF']}, {'name': 'Tenofovir alafenamide', 'type': 'DRUG', 'otherNames': ['GS-7340'], 'description': 'Tenofovir alafenamide tablet(s) administered orally once daily', 'armGroupLabels': ['Tenofovir alafenamide 150 mg', 'Tenofovir alafenamide 50 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Positive Care Program', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Protocare Trials Chicago Center for Clinical Trials', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Rockefeller University Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}