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 Squibb (BMS)

Status and phase

Completed

Phase 3

Conditions

HIV Infections

Treatments

Drug: Sustiva

Drug: Epivir

Drug: Videx EC

Study type

Interventional

Funder types

Industry

Identifiers

NCT00135382

AI266-406

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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