HIV Infections
Conditions
Keywords
treatment naive
Brief summary
This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir DF).
Interventions
DRUGTenofovir DF
Tenofovir DF tablet administered orally once daily
DRUGTenofovir alafenamide
Tenofovir alafenamide tablet(s) administered orally once daily
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* HIV-1 RNA levels greater than or equal to 30,000 copies/mL * CD4 count greater than or equal to 200 cells/mm3 * Serum creatinine \<1.5 mg/dl * Hepatic transaminases less than or equal to 2.5 times the upper limit of normal * Total bilirubin less than or equal to 1.5 mg/dL * Adequate hematologic function * Serum amylase less than or equal to 1.5 times the upper limit of normal * Serum phosphate greater than or equal to 2.2 mg/dL * Not pregnant
Exclusion criteria
* Prior treatment with antiretroviral therapy * Immunization within 30 days of study entry * A new AIDS defining condition within 30 days of study entry * Receiving nephrotoxic agents, probenecid, chemotherapeutic agents, corticosteroids, interleukin-2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed