HIV Infections
Conditions
Keywords
HIV, HIV-1, AIDS, Human Immunodeficiency Virus, HIV-1 Infection
Brief summary
To compare the effectiveness (efficacy, safety & tolerability) of a Single Tablet Regimen of efavirenz/emtricitabine/tenofovir DF to subjects continuing on unmodified HAART as measured by the proportion of patients who maintain viral load (HIV-1 RNA) \<200 copies/mL at Week 48.
Interventions
DRUGEfavirenz (EFV), Emtricitabine (FTC), Tenofovir DF (TDF)
Sponsors
Bristol-Myers Squibb
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* HIV-1 positive patients who have maintained an HIV-1 viral load \<200 copies/mL, for at least 3 months. * Patients must be on their first HAART or have documented viral suppression on a PI-based regimen at the time of any prior change in therapy. * HAART must consist of either: 1. A PI (with or without ritonavir) + at least 2 NRTIs or 2. An NNRTI + at least 2 NRTIs. * Negative serum pregnancy test.
Exclusion criteria
* Patients who have taken any NNRTI prior to their current therapy. * Patients who have taken a NRTI-only therapy for greater than 7 days prior to their current therapy. * Patients who are currently taking EFV+FTC+TDF. * Patients who have a creatinine clearance of \<60 mL/min by Cockcroft-Gault estimation. * Patients who have experienced virologic failure with any previous ARV therapy. * Patients who have documented resistance to any of the study agents at any time in the past.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: Proportion of patients with HIV-1 RNA levels <200 copies/mL at Week 48 | — |
| Safety Outcome Measures: Adverse Events, Laboratory Tests | — |
| Outcomes Research Measures: Quality of life, adherence, preference of medication, perceived ease of regimen, HIV symptoms | — |
Countries
Puerto Rico, United States
Outcome results
None listed