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NCT00036452 · ClinicalTrials.gov registry record · Phase 2
A Study to Compare Anti-HIV Drugs Given Twice a Day or Once a Day, With or Without Direct Observation
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 402
- Enrollment target
NCT00036452: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00036452 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 402 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (202% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00036452, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 402 participants
- Enrollment target
Study Summary
Anti-HIV drug therapy works best when the drugs are taken exactly as prescribed by a doctor. Because anti-HIV therapy often involves multiple drugs, some people have difficulty taking them all correctly. The easier it is to take anti-HIV drugs, the more likely people will take them as prescribed and get the best results. This study will see if people are more successful in taking anti-HIV drugs once a day or twice a day. It also will determine if having a health care professional oversee each weekday dose helps people control their HIV infection. The study will compare taking a three-drug combination twice a day versus taking a three-drug combination just once a day. The study will also compare patients taking the drugs on their own to patients taking the drugs in the presence of a clinical worker. Viral load (amount of HIV in the blood) and drug side effects will be measured.
Interventions
- DRUG emtricitabine
- DRUG lopinavir/ritonavir
- DRUG stavudine
- DRUG tenofovir DF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 402 participants |
| Est. Completion | 2006-01 |
| Phase | Phase 2 |
What the finished NCT00036452 record still lists
NCT00036452 is an interventional study that assigns participants to a tested intervention. The registered 402 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (202% higher).
The record links to 0 conditions, and to 4 interventions - of which emtricitabine is the first listed.
NCT00036452 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00036452 about?
NCT00036452 is a clinical study titled "A Study to Compare Anti-HIV Drugs Given Twice a Day or Once a Day, With or Without Direct Observation". Anti-HIV drug therapy works best when the drugs are taken exactly as prescribed by a doctor. Because anti-HIV therapy often involves multiple drugs, some people have difficulty taking them all correctly. The easier it is to take anti-HIV drugs, the more likely people will take them as prescribed and...
What is the current status of trial NCT00036452?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 402 participants. Estimated completion is 2006-01.
What interventions are being tested in trial NCT00036452?
The interventions under investigation include: emtricitabine (DRUG), lopinavir/ritonavir (DRUG), stavudine (DRUG), tenofovir DF (DRUG).
Who is sponsoring clinical trial NCT00036452?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00036452's enrollment target sits among peer trials
402 96th of 2000 higher than 1,905 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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