Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Efavirenz; HIV Protease Inhibitors; Protease Inhibitors

Criteria

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