Who is sponsoring NCT00135369?

NCT00135369 is sponsored by Bristol-Myers Squibb.

What condition does NCT00135369 study?

NCT00135369 studies HIV Infections.

What drugs are being tested in NCT00135369?

Interventions: stavudine extended-release, lamivudine, efavirenz.

What is the status of NCT00135369?

NCT00135369 is currently COMPLETED.

Last reviewed 2011-04-08 · How we verify

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

NCT00135369 Phase 3 COMPLETED

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.

Details

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 3
Status	COMPLETED
Enrolment	300
Start date	2002-09
Completion	2005-07

Conditions

HIV Infections

Interventions

stavudine extended-release, lamivudine, efavirenz

Primary outcomes

Efficacy at week 48

Countries

United States, Puerto Rico