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NCT00242216 · ClinicalTrials.gov registry record · Phase 4
"The Once A Day Protease Inhibitor Regimens"
A Phase 4 study of HIV Infections, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 4
- Development phase
- 76
- Enrollment target
- 1
- Study location
NCT00242216 is a Phase 4 study of HIV Infections that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 76 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00242216, a Phase 4 study of HIV Infections, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 76 participants
- Enrollment target
- 1
- Study location
Study Summary
Atazanavir (ATV) and fosamprenavir (fAPV) are new protease inhibitors that can be administered once-a-day and boosted with ritonavir (r). Prior studies have demonstrated that both are effective in treatment of ARV-naïve HIV-infected people. This study was designed to demonstrate if a HAART regimen containing ATV/r is not inferior to a HAART regimen containing fAPV/r, in ARV-naïve patients over a 96-week period. This is a phase IV, single center, randomized, open label, 2-arm clinical trial in ARV therapy-naïve patients with HIV-1 RNA \>1,000 copes/mL and CD4 cell count \<350 cells/mm3. Patients will be randomized to receive tenofovir and emtricitabine plus either ATV (300mg qd) and ritonavir (100mg qd) or fAPV (1400mg qd) and ritonavir (200mg qd).
Conditions Studied
Interventions
- DRUG ritonavir-boosted atazanavir
- DRUG ritonavir-boosted fosamprenavir
Study Locations (1)
Texas
- Thomas Street Health Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2004-05 |
| Est. Completion | 2010-03 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00242216
The ClinicalTrials.gov registry entry for NCT00242216 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 76 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 (83% lower). The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which ritonavir-boosted atazanavir is the first listed.
NCT00242216 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00242216 about?
NCT00242216 is a clinical study titled ""The Once A Day Protease Inhibitor Regimens"". Atazanavir (ATV) and fosamprenavir (fAPV) are new protease inhibitors that can be administered once-a-day and boosted with ritonavir (r). Prior studies have demonstrated that both are effective in treatment of ARV-naïve HIV-infected people. This study was designed to demonstrate if a HAART regimen c...
What is the current status of trial NCT00242216?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 76 participants. The study started on 2004-05. Estimated completion is 2010-03.
What conditions does trial NCT00242216 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00242216?
The interventions under investigation include: ritonavir-boosted atazanavir (DRUG), ritonavir-boosted fosamprenavir (DRUG).
Who is sponsoring clinical trial NCT00242216?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00242216 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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