NCT00135382CompletedPhase 3
A Phase 3 Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen
Bristol-Myers Squibb48 sites in 2 countries254 target enrollmentStarted: June 1, 2002Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 254
- Locations
- 48
- Primary Endpoint
- Efficacy at week 48
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Efficacy at week 48
Secondary Outcomes
- 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
Investigators
Study Sites (48)
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