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NCT00915655 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents
A Phase 2 study, sponsored by Tibotec Pharmaceuticals, Ireland.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT00915655: Completed Phase 2 study, sponsored by Tibotec Pharmaceuticals, Ireland.
NCT00915655 is a Phase 2 study that has completed, run by Tibotec Pharmaceuticals, Ireland. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00915655, a Phase 2 study, has completed, sponsored by Tibotec Pharmaceuticals, Ireland.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate pharmacokinetics (what body does to medication), safety, tolerability, and efficacy (effectiveness) of darunavir with low-dose ritonavir (DRV/rtv) administered once daily, in combination with an investigator-selected background regimen consisting of other antiretrovirals (ARVs) ie, 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), in treatment-naive (never treated before) HIV-1 infected adolescents aged from 12 to \<18 years and weighing at least 40 kg.
Primary Outcome
The analysis is based on virologic response defined as percentage of patients with confirmed plasma viral load \<50 HIV-1 RNA copies/mL at Week 24 calculated according to the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) algorithm.
Interventions
- DRUG lamivudine
- DRUG ritonavir
- DRUG darunavir
- DRUG zidovudine
- DRUG abacavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2009-07 |
| Est. Completion | 2011-03 |
| Phase | Phase 2 |
What the finished NCT00915655 record still lists
NCT00915655 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 5 interventions - of which lamivudine is the first listed.
NCT00915655 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00915655 about?
NCT00915655 is a clinical study titled "A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents". The purpose of this study is to evaluate pharmacokinetics (what body does to medication), safety, tolerability, and efficacy (effectiveness) of darunavir with low-dose ritonavir (DRV/rtv) administered once daily, in combination with an investigator-selected background regimen consisting of other ant...
What is the current status of trial NCT00915655?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2009-07. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00915655?
The interventions under investigation include: lamivudine (DRUG), ritonavir (DRUG), darunavir (DRUG), zidovudine (DRUG), abacavir (DRUG).
Who is sponsoring clinical trial NCT00915655?
This trial is sponsored by Tibotec Pharmaceuticals, Ireland, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00915655's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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