Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00116116 · ClinicalTrials.gov registry record · Phase 4
DART II - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated With Antiretroviral Therapy
A Phase 4 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 4
- Development phase
- 70
- Enrollment target
NCT00116116: Completed Phase 4 study, sponsored by Bristol-Myers Squibb.
NCT00116116 is a Phase 4 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 70 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00116116, a Phase 4 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 70 participants
- Enrollment target
Study 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.
Interventions
- DRUG efavirenz, stavudine extended release, lamivudine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2002-03 |
| Est. Completion | 2005-06 |
| Phase | Phase 4 |
What the finished NCT00116116 record still lists
NCT00116116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which efavirenz, stavudine extended release, lamivudine is the first listed.
NCT00116116 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00116116 about?
NCT00116116 is a clinical study titled "DART II - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated With Antiretroviral Therapy". 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.
What is the current status of trial NCT00116116?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2002-03. Estimated completion is 2005-06.
What interventions are being tested in trial NCT00116116?
The interventions under investigation include: efavirenz, stavudine extended release, lamivudine (DRUG).
Who is sponsoring clinical trial NCT00116116?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00116116's enrollment target sits among peer trials
70 1043rd of 2000 higher than 931 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00969111 · 70 participants · NA
Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
- NCT01712620 · 70 participants · Phase 2
Spironolactone for Pulmonary Arterial Hypertension
- NCT02143830 · 70 participants · Phase 2
HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy
- NCT02601339 · 70 participants
NIRS Monitoring in Premature Infants
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia