Clinical Trials Directory

Trials / Completed

CompletedNCT00116415

DART I - 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 1): An Open-Label, Single-Arm, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Didanosine Enteric Coated (Ddl-EC) in Combination With Lamivudine (3TC) and Efavirenz (EFV) Once Daily in Anti-Retroviral Therapy (ART) Naive HIV-Infected Patients

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
65 (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 efavirenz (EFV), didanosine (ddI)-EC and lamivudine (3TC) leads to improved outcomes, as measured by viral load, CD4 counts, adherence, safety, and tolerability.

Conditions

Interventions

TypeNameDescription
DRUGefavirenz; didanosine EC; lamivudine

Timeline

Start date
2002-03-01
Primary completion
2004-11-01
Completion
2004-11-01
First posted
2005-06-30
Last updated
2011-04-22

Locations

9 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00116415. Inclusion in this directory is not an endorsement.