Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen
Phase 3
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT00135382
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a protease inhibitor (PI)-based regimen to an efavirenz-based regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels \< 50 copies/mL. In addition, a simplified once-daily regimen will improve adherence and quality of life.
- Detailed Description
Patients randomized to the non Videx enteric coated (ddl EC)+lamivudine (3TC)+efavirenz (EFV) arm would continue their baseline nucleoside reverse transcriptase inhibitors (NRTIs) on study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 254
Inclusion Criteria
- Documented HIV infection
- ≥ 18 years of age and weight at least 40kg
- Two plasma HIV RNA levels < 50 copies/mL during the qualification and screening period
- Patients receiving a PI and ≥ 2 NRTIs
Exclusion Criteria
- Pregnancy or breastfeeding
- Documented virologic failure while on their first PI-based antiretroviral (ARV) regimen
- Active AIDS-defining opportunistic infection or disease
- Proven or suspected acute hepatitis within 30 days prior to study entry
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Efficacy at week 48
- Secondary Outcome Measures
Name Time Method Safety, tolerability and efficacy at weeks (wks) 24 and 48; Effect on lipids at wks 24 and 48; Adherence, quality of life changes, treatment satisfaction and preference at wks 12, 24 and 48
Trial Locations
- Locations (1)
Local Institution
🇵🇷Rio Piedras, Puerto Rico