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 Squibb1 site in 1 country254 target enrollmentJune 2002

ConditionsHIV Infections

DrugsVidex EC Epivir Sustiva

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: HIV Infections
Sponsor: Bristol-Myers Squibb
Enrollment: 254
Locations: 1
Primary Endpoint: Efficacy at week 48
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

June 2002

End Date

October 2005

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Eligibility 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

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