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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 is a Phase 2 study that has completed, run by Tibotec Pharmaceuticals, Ireland. The registered enrollment target is 12 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00915655
The ClinicalTrials.gov registry entry for NCT00915655 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tibotec Pharmaceuticals, Ireland, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which lamivudine is the first listed.
NCT00915655 reports 0 study locations.
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.
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