NCT00116116

DART II - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated With Antiretroviral Therapy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (planned)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• HIV Infections
• AIDS

Interventions

Type	Name	Description
DRUG	efavirenz, stavudine extended release, lamivudine

Timeline

• Start date: 2002-03-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2005-06-28
• Last updated: 2011-04-26

Locations

10 sites across 1 country: United States