A Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive Patients
- Registration Number
- NCT00036634
- Lead Sponsor
- Gilead Sciences
- Brief Summary
This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir DF).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tenofovir DF Tenofovir DF Participants received tenofovir DF 300 mg for 14 days Tenofovir alafenamide 50 mg Tenofovir alafenamide Participants received tenofovir alafenamide 50 mg for 14 days Tenofovir alafenamide 150 mg Tenofovir alafenamide Participants received tenofovir alafenamide 150 mg for 14 days
- Primary Outcome Measures
Name Time Method Time-weighted average change from baseline through Week 2 (DAVG2) for HIV-1 RNA (log10 copies/mL) Baseline to Week 2 DAVG2 was defined as the time-weighted average between baseline value through the last available value up to week 2 minus the baseline value.
- Secondary Outcome Measures
Name Time Method Change from baseline in HIV-1 RNA (log10 copies/mL) Baseline to Week 2 Change from baseline in CD4 cell count (cells/mm3) Baseline to Week 2
Trial Locations
- Locations (3)
Rockefeller University Hospital
🇺🇸New York, New York, United States
Protocare Trials Chicago Center for Clinical Trials
🇺🇸Chicago, Illinois, United States
Stanford Positive Care Program
🇺🇸Palo Alto, California, United States