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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00931801
The ClinicalTrials.gov registry entry for NCT00931801 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Community Research Initiative of New England, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which atazanavir/raltegravir is the first listed.
NCT00931801 reports 0 study locations.
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.
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