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NCT01388543 · ClinicalTrials.gov registry record · Phase 4
Genetics and HIV-1 Protease Inhibitors
A Phase 4 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 4
- Development phase
- 31
- Enrollment target
NCT01388543: Completed Phase 4 study, sponsored by University of Colorado, Denver.
NCT01388543 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 31 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01388543, a Phase 4 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 31 participants
- Enrollment target
Study Summary
This study evaluated the blood levels of atazanavir according to a genetic makeup for CYP3A5 (cytochrome P450 3A5, an enzyme that metabolizes atazanavir). The hypothesis was that people with a slow-metabolizing genotype would have higher blood levels of atazanavir compared to people with the normal metabolizing genotype.
Primary Outcome
Measure atazanavir oral clearance in genetically-determined CYP3A5 expressors versus CYP3A5 non-expressors
Interventions
- DRUG Atazanavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2006-09 |
| Est. Completion | 2008-06 |
| Phase | Phase 4 |
What the finished NCT01388543 record still lists
NCT01388543 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Atazanavir is the first listed.
NCT01388543 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01388543 about?
NCT01388543 is a clinical study titled "Genetics and HIV-1 Protease Inhibitors". This study evaluated the blood levels of atazanavir according to a genetic makeup for CYP3A5 (cytochrome P450 3A5, an enzyme that metabolizes atazanavir). The hypothesis was that people with a slow-metabolizing genotype would have higher blood levels of atazanavir compared to people with the normal ...
What is the current status of trial NCT01388543?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 31 participants. The study started on 2006-09. Estimated completion is 2008-06.
What interventions are being tested in trial NCT01388543?
The interventions under investigation include: Atazanavir (DRUG).
Who is sponsoring clinical trial NCT01388543?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01388543's enrollment target sits among peer trials
31 1544th of 2000 higher than 449 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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