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NCT00543101 · ClinicalTrials.gov registry record · Phase 4
Efficacy Study of Substitution of Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors
A Phase 4 study, sponsored by Community Research Initiative of New England.
- Completed
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
NCT00543101: Completed Phase 4 study, sponsored by Community Research Initiative of New England.
NCT00543101 is a Phase 4 study that has completed, run by Community Research Initiative of New England. The registered enrollment target is 24 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00543101, a Phase 4 study, has completed, sponsored by Community Research Initiative of New England.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study will evaluate patients who have achieved virologic suppression (\< 400 copies/mL) on any dual protease inhibitor (PI) combination, to determine whether patients can substitute both PIs with the single boosted PI darunavir given 600/100 ritonavir (RTV) twice daily (BID) and maintain comparable virologic suppression (% \< 50 c/mL) for 24 weeks.
Primary Outcome
Amount of HIV RNA copies per ml blood collected from subjects as measured by the Ultra-sensitive HIV-1 PCR (Roche Cobas). Successful virologic suppression is defined as \< 50 copies/ml blood. The result is the percentage of participants with successful virologic suppression.
Interventions
- DRUG Darunavir (DRV/r)
- DRUG continue on current dual boosted PI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2007-10 |
| Est. Completion | 2010-02 |
| Phase | Phase 4 |
What the finished NCT00543101 record still lists
NCT00543101 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Darunavir (DRV/r) is the first listed.
NCT00543101 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00543101 about?
NCT00543101 is a clinical study titled "Efficacy Study of Substitution of Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors". This study will evaluate patients who have achieved virologic suppression (\< 400 copies/mL) on any dual protease inhibitor (PI) combination, to determine whether patients can substitute both PIs with the single boosted PI darunavir given 600/100 ritonavir (RTV) twice daily (BID) and maintain compar...
What is the current status of trial NCT00543101?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2007-10. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00543101?
The interventions under investigation include: Darunavir (DRV/r) (DRUG), continue on current dual boosted PI (DRUG).
Who is sponsoring clinical trial NCT00543101?
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 NCT00543101's enrollment target sits among peer trials
24 1699th of 2000 higher than 276 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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