Who is sponsoring NCT00116298?

NCT00116298 is sponsored by Bristol-Myers Squibb.

What condition does NCT00116298 study?

NCT00116298 studies HIV Infections, AIDS.

What drugs are being tested in NCT00116298?

Interventions: stavudine, efavirenz, lamivudine.

What is the status of NCT00116298?

NCT00116298 is currently COMPLETED.

Last reviewed 2011-04-08 · How we verify

A Study to Compare Long-Term Safety and Tolerability of Stavudine (d4T) Extended Release (ER) Versus Conventional (Immediate Release, IR) Formulations, Each In Combination With Lamivudine (3TC) and Efavirenz (EFV) in Subjects Who Have Completed BMS Studies AI455-096 and AI455-099

NCT00116298 Phase 3 COMPLETED

The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T) extended release (ER) versus conventional (immediate release \[IR\]) formulations, each in combination with lamivudine (3TC) and efavirenz (EFV) in subjects who have completed Bristol-Myers Squibb (BMS) studies AI455-096 and AI455-099.

Details

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 3
Status	COMPLETED
Enrolment	900
Start date	2001-01
Completion	2005-01

Conditions

HIV Infections
AIDS

Interventions

stavudine, efavirenz, lamivudine

Primary outcomes

Safety: Frequency and severity of AEs, and treatment discontinuations for AEs; population trends for triglycerides and cholesterol. Primary efficacy outcome: proportion of subjects with HIVRNA <400, <50, and change in viral load over the study period

Countries

United States, Argentina, Belgium, Brazil, Canada, France, Israel, Italy, Mexico, Portugal, Puerto Rico, Russia, Singapore, South Africa, Spain, Thailand