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NCT00940771 · ClinicalTrials.gov registry record · Phase 4
Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens
A Phase 4 study of HIV Infections and Pediatric HIV, sponsored by Phoenix Children's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT00940771 is a Phase 4 study of HIV Infections and Pediatric HIV that has completed, run by Phoenix Children's Hospital. The registered enrollment target is 10 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00940771, a Phase 4 study of HIV Infections and Pediatric HIV, has completed, sponsored by Phoenix Children's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The hypothesis for this study is whether a treatment regimen containing Atazanavir in combination with Ritonavir will work as well as other regimens containing a protease inhibitor and/or a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) at controlling HIV disease in children who are HIV+ and have high cholesterol or high triglycerides. . In this study, children who have high cholesterol or high triglycerides as a result of their HIV medicines, will have the PI or NNRTI in their medication regimen changed to Atazanavir, which is a PI in combination with a low dose of Ritonavir (another PI). Atazanavir has been shown in adults to result in lower cholesterol and triglycerides than other PI's and NNRTI's. The dose of Atazanavir and Ritonavir will be according to the Package Insert for this drug that is FDA approved for children. They will continue taking the other medications from the pre-study regimen. Children will take study drug for 24 weeks, and will be able to continue study drug after the study using commercially available drug. Lab tests and a physical exam will be undertaken at 4 weeks, 12 weeks and 24 weeks after starting study drug to determine how effective the new drug is and to monitor for possible side effects.
Conditions Studied
Interventions
- DRUG Boosted Atazanavir
Study Locations (1)
Arizona
- Phoenix Children's Hospital - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2009-08-26 |
| Est. Completion | 2016-11-23 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00940771
The ClinicalTrials.gov registry entry for NCT00940771 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (98% lower). The listed sponsor is Phoenix Children's Hospital, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Boosted Atazanavir is the first listed.
NCT00940771 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.
Frequently Asked Questions
What is clinical trial NCT00940771 about?
NCT00940771 is a clinical study titled "Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens". The hypothesis for this study is whether a treatment regimen containing Atazanavir in combination with Ritonavir will work as well as other regimens containing a protease inhibitor and/or a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) at controlling HIV disease in children who are HIV+ and...
What is the current status of trial NCT00940771?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2009-08-26. Estimated completion is 2016-11-23.
What conditions does trial NCT00940771 study?
This clinical trial studies the following conditions: HIV Infections, Pediatric HIV.
What interventions are being tested in trial NCT00940771?
The interventions under investigation include: Boosted Atazanavir (DRUG).
Who is sponsoring clinical trial NCT00940771?
This trial is sponsored by Phoenix Children's Hospital, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00940771 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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