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NCT00281606 · ClinicalTrials.gov registry record · Phase 4
A Multicenter Study to Assess the Tolerability of Once Daily Lopinavir/Ritonavir (LPV/r) Liquid Versus Capsules
A Phase 4 study of HIV Infection, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 4
- Development phase
- 65
- Enrollment target
- 5
- Study locations
NCT00281606: Completed Phase 4 study of HIV Infection, sponsored by University of California, San Diego.
NCT00281606 is a Phase 4 study of HIV Infection that has completed, run by University of California, San Diego. The registered enrollment target is 65 participants, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (73% lower). The trial reports 5 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00281606, a Phase 4 study of HIV Infection, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 65 participants
- Enrollment target
- 5
- Study locations
Study Summary
Guidelines have continued to list lopinavir/ritonavir as a preferred protease inhibitor-containing regimen for HIV-infected individuals. There has recently been increasing interest in once daily therapy. While lopinavir/ritonavir has recently been approved as a once daily therapy it was associated with considerable diarrhea in those treated with soft gel capsules. It is the hope that alternative formulations of lopinavir/ritonavir may provide similar pharmacokinetics with improved tolerability. This includes the possibility of using liquid or newly released tablets. This study will treat people tolerating their current regimen with up to four weeks of each formulation with several assessments of pharmacokinetics and tolerability for each.
Primary Outcome
To assess the comparative tolerability of once daily Lopinavir/ritonavir \[LPV/r\] (800/200 mg) as 10 ml liquid vs. 6 soft gel capsules by measuring incidence rates as assessed by the CTCAE v4.0 in each arm of: a) grade 2 or higher diarrhea plus b) dose limiting toxicity of any kind.
Conditions Studied
Interventions
- DRUG Different formulations of once-daily lopinavir/ritonavir
Study Locations (5)
California
- UCI - Irvine
- USC - Los Angeles
- UCSD - San Diego
- Santa Clara Valley Medical Center - San Jose
- Harbor-UCLA Medical Center - Torrance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2006-02-14 |
| Est. Completion | 2012-06-13 |
| Phase | Phase 4 |
What the finished NCT00281606 record still lists
NCT00281606 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (73% lower).
The record links to 1 condition, with HIV Infection appearing as the primary indexed condition, and to 1 intervention - of which Different formulations of once-daily lopinavir/ritonavir is the first listed.
NCT00281606 lists 5 locations in 1 state (California).
Frequently Asked Questions
What is clinical trial NCT00281606 about?
NCT00281606 is a clinical study titled "A Multicenter Study to Assess the Tolerability of Once Daily Lopinavir/Ritonavir (LPV/r) Liquid Versus Capsules". Guidelines have continued to list lopinavir/ritonavir as a preferred protease inhibitor-containing regimen for HIV-infected individuals. There has recently been increasing interest in once daily therapy. While lopinavir/ritonavir has recently been approved as a once daily therapy it was associated w...
What is the current status of trial NCT00281606?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 65 participants. The study started on 2006-02-14. Estimated completion is 2012-06-13.
What conditions does trial NCT00281606 study?
This clinical trial studies the following conditions: HIV Infection.
What interventions are being tested in trial NCT00281606?
The interventions under investigation include: Different formulations of once-daily lopinavir/ritonavir (DRUG).
Who is sponsoring clinical trial NCT00281606?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00281606 being conducted?
This trial has 5 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00281606's enrollment target sits among peer trials
65 33rd of 73 higher than 41 of 73 other HIV Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infection 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.
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