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Completed Phase 4 Interventional

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

ClinicalTrials.gov ID: NCT00116116

Public ClinicalTrials.gov record NCT00116116. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 7:01 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00116116
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Bristol-Myers Squibb
Industry
Enrollment
70 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2002
Primary completion
May 31, 2005
Completion
May 31, 2005
Last update posted
Apr 25, 2011

2002 – 2005

United States locations

U.S. sites
10
U.S. states
7
U.S. cities
10
Facility City State ZIP Site status
Local Institution Bakersfield California
Local Institution San Francisco California
Local Institution Washington D.C. District of Columbia
Local Institution Fort Lauderdale Florida
Local Institution Jacksonville Florida
Local Institution Miami Florida
Local Institution New York New York
Local Institution Greenville North Carolina
Local Institution Oklahoma City Oklahoma
Local Institution Dallas Texas

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00116116, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 25, 2011 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00116116 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →