Who is sponsoring NCT00116116?

NCT00116116 is sponsored by Bristol-Myers Squibb.

What condition does NCT00116116 study?

NCT00116116 studies HIV Infections, AIDS.

What drugs are being tested in NCT00116116?

Interventions: efavirenz, stavudine extended release, lamivudine.

What is the status of NCT00116116?

NCT00116116 is currently COMPLETED.

Last reviewed 2011-04-14 · How we verify

Daily Antiretroviral Therapy (DART-II): An Open-Label, Single-Arm, Prospective, Multicenter Clinical Trial To Evaluate the Efficacy and Safety fo Stavudine Extended Release (d4T XR) in Combination With Lamivudine (3TC) and Efavirenz (EFV) Once Daily in Anti-Retroviral Therapy (ART) Naive HIV-Infected Subjects

NCT00116116 Phase 4 COMPLETED

The purpose of this study is to evaluate whether a therapy with an all once daily regimen of stavudine extended release (d4T XR), lamivudine (3TC), and efavirenz (EFV) leads to improved outcomes, as measured by viral load, CD4 counts, adherence, safety, and tolerability.

Details

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 4
Status	COMPLETED
Enrolment	70
Start date	2002-03
Completion	2005-06

Conditions

HIV Infections
AIDS

Interventions

efavirenz, stavudine extended release, lamivudine

Primary outcomes

Estimate efficacy of d4T-XR/3TC/EFV given QD determined by
proportion of patients with plasma HIV RNA < 400 copies/mL after 48 weeks

Countries

United States