Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed Not applicable Interventional

DART I - 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: NCT00116415

Public ClinicalTrials.gov record NCT00116415. 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 Oct 22, 2026, 5:46 PM 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 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

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 efavirenz (EFV), didanosine (ddI)-EC and lamivudine (3TC) leads to improved outcomes, as measured by viral load, CD4 counts, adherence, safety, and tolerability.

Study identification

NCT ID
NCT00116415
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Bristol-Myers Squibb
Industry
Enrollment
65 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
Mar 2002 (Type not available)
Primary completion
Nov 2004 (Actual)
Completion
Nov 2004 (Actual)
Last update posted
Apr 22, 2011

2002 – 2004

United States locations

U.S. sites
9
U.S. states
8
U.S. cities
9
Facility City State ZIP Site status
Local Institution Washington D.C. District of Columbia — —
Local Institution Orlando Florida — —
Local Institution Columbus Georgia — —
Local Institution Boston Massachusetts — —
Local Institution Springfield Massachusetts — —
Local Institution Kansas City Missouri — —
Local Institution Hillsborough New Jersey — —
Local Institution The Bronx New York — —
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 NCT00116415, 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 22, 2011 · Synced Oct 22, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00116415 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →