A Phase 3 Study Switching HIV-1 Infected Subjects With an Undetectable Viral Load From a HAART Regimen Dosed Twice Daily or More Frequently to a Once-Daily HAART Regimen

Bristol-Myers Squibb1 site in 1 country300 target enrollmentSeptember 2002

ConditionsHIV Infections

Drugsstavudine extended-release, lamivudine, efavirenz

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: HIV Infections
Sponsor: Bristol-Myers Squibb
Enrollment: 300
Locations: 1
Primary Endpoint: Efficacy at week 48
Status: Completed
Last Updated: 15 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 standard-of-care regimen dosed twice-daily or more frequently to a simpler once-daily (QD) regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels <50 copies/mL after switching to a QD regimen.

Registry

clinicaltrials.gov

Start Date

September 2002

End Date

July 2005

Last Updated

15 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 or older and weigh at least 40 kg
•Two plasma HIV RNA levels below the limit of quantification (one at least 90 days prior to the screening visit and one within 30 days of the patients baseline visit)
•Currently receiving a standard-of-care HAART regimen with at least one agent being dosed twice-daily or more frequently

Exclusion Criteria

•Pregnancy, breastfeeding or plans to become pregnant during the study period
•Any prior documented virologic failure to one or more HAART regimens
•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