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NCT00084136 · ClinicalTrials.gov registry record · Phase 4
Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings
A Phase 4 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,571
- Enrollment target
NCT00084136: Completed Phase 4 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
NCT00084136 is a Phase 4 study that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 1,571 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (203% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00084136, a Phase 4 study, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,571 participants
- Enrollment target
Study Summary
This study compared 3 different three-drug combinations in HIV infected individuals starting their first HIV treatment regimens. Participants were recruited from resource-limited areas in Africa, Asia, South America, Haiti, and also from the United States. The study hypothesis was each of the once daily combinations (PI based, or NNRTI based) would not have inferior efficacy compared to the twice daily NNRTI based combination.
Primary Outcome
Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005), plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). P
Interventions
- DRUG Atazanavir
- DRUG Efavirenz
- DRUG Emtricitabine
- DRUG Emtricitabine/Tenofovir disoproxil fumarate
- DRUG Didanosine (enteric-coated)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,571 participants |
| Start Date | 2005-05 |
| Est. Completion | 2010-05 |
| Phase | Phase 4 |
What the finished NCT00084136 record still lists
NCT00084136 is an interventional study that assigns participants to a tested intervention. Its 1,571 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (203% higher).
The record links to 0 conditions, and to 5 interventions - of which Atazanavir is the first listed.
NCT00084136 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00084136 about?
NCT00084136 is a clinical study titled "Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings". This study compared 3 different three-drug combinations in HIV infected individuals starting their first HIV treatment regimens. Participants were recruited from resource-limited areas in Africa, Asia, South America, Haiti, and also from the United States. The study hypothesis was each of the once d...
What is the current status of trial NCT00084136?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,571 participants. The study started on 2005-05. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00084136?
The interventions under investigation include: Atazanavir (DRUG), Efavirenz (DRUG), Emtricitabine (DRUG), Emtricitabine/Tenofovir disoproxil fumarate (DRUG), Didanosine (enteric-coated) (DRUG).
Who is sponsoring clinical trial NCT00084136?
This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00084136's enrollment target sits among peer trials
1,571 50th of 2000 higher than 1,951 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
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