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NCT00931801 · ClinicalTrials.gov registry record · Phase 4
BATAR: Individuals Currently Taking Boosted Atazanavir as Part of an HIV Treatment Regimen Will be Evaluated to See if Substituting Raltegravir for Nucleoside Transcriptase Inhibitors Will be Safe and Well Tolerated.
A Phase 4 study, sponsored by Community Research Initiative of New England.
- Completed
- Registry status
- Phase 4
- Development phase
- 43
- Enrollment target
NCT00931801: Completed Phase 4 study, sponsored by Community Research Initiative of New England.
NCT00931801 is a Phase 4 study that has completed, run by Community Research Initiative of New England. The registered enrollment target is 43 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00931801, a Phase 4 study, has completed, sponsored by Community Research Initiative of New England.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 43 participants
- Enrollment target
Study Summary
The purpose of this Phase IV pilot study is to evaluate the safety, tolerability, and satisfaction of a nucleoside analog reverse-transcriptase inhibitors (NRTI)sparing regimen for participants fully suppressed on an atazanavir/ritonavir based highly active antiretroviral therapy (HAART)regimen plus emtricitabine/tenofovir (Truvada). Several pharmacologic factors support this concept including the favorable drug interaction between atazanavir and raltegravir. Participants will be randomized to either continue on their current regimen or one of two study arms (atazanavir 300mg plus ritonavir 100mg daily plus raltegravir 400mg twice daily or atazanavir 300mg twice daily plus raltegravir 400mg twice daily). Participants will be followed for 48 weeks for safety, tolerability, and satisfaction. After baseline, the participants will have six clinic visits for evaluation and labs.
Primary Outcome
To evaluate and compare maintenance of virologic suppression with raltegravir (RAL) 400mg 2x daily plus atazanavir (ATV) dosed either as ATV/ritonavir (RTV)300/100mg 1x daily or ATV 300mg 2x daily in subjects with virologic suppression on a standard regimen of ATV/RTV plus Truvada. Virologic suppression is defined as HIV RNA \< 40 copies/mL.
Interventions
- DRUG atazanavir/raltegravir
- DRUG atazanavir/tenofovir/emtricitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2009-12 |
| Est. Completion | 2012-03 |
| Phase | Phase 4 |
What the finished NCT00931801 record still lists
NCT00931801 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which atazanavir/raltegravir is the first listed.
NCT00931801 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00931801 about?
NCT00931801 is a clinical study titled "BATAR: Individuals Currently Taking Boosted Atazanavir as Part of an HIV Treatment Regimen Will be Evaluated to See if Substituting Raltegravir for Nucleoside Transcriptase Inhibitors Will be Safe and Well Tolerated.". The purpose of this Phase IV pilot study is to evaluate the safety, tolerability, and satisfaction of a nucleoside analog reverse-transcriptase inhibitors (NRTI)sparing regimen for participants fully suppressed on an atazanavir/ritonavir based highly active antiretroviral therapy (HAART)regimen plus...
What is the current status of trial NCT00931801?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 43 participants. The study started on 2009-12. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00931801?
The interventions under investigation include: atazanavir/raltegravir (DRUG), atazanavir/tenofovir/emtricitabine (DRUG).
Who is sponsoring clinical trial NCT00931801?
This trial is sponsored by Community Research Initiative of New England, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00931801's enrollment target sits among peer trials
43 1371st of 2000 higher than 621 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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