Status:
COMPLETED
Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 wh...
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT00135382
Start Date
June 1 2002
End Date
October 1 2005
Last Update
February 17 2010
Active Locations (48)
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1
Local Institution
Little Rock, Arkansas, United States
2
Local Institution
Beverly Hills, California, United States
3
Local Institution
Fountain Valley, California, United States
4
Local Institution
Long Beach, California, United States