DART I - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated With Antiretroviral Therapy
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.
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
- Enrollment
- 65 participants
Conditions and interventions
Conditions
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
- Oct 31, 2004
- Completion
- Oct 31, 2004
- Last update posted
- Apr 21, 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 21, 2011 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00116415 live on ClinicalTrials.gov.