Single Tablet Regimen (STR) Simplification Study for HIV-1 Infected Patients
Phase 4
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT00365612
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
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:
- A PI (with or without ritonavir) + at least 2 NRTIs or
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method