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NCT00363142 · ClinicalTrials.gov registry record · Phase 3
A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 211
- Enrollment target
NCT00363142: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00363142 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 211 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00363142, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 211 participants
- Enrollment target
Study Summary
This is a 24-week study to evaluate the efficacy and safety of a once-daily ritonavir-boosted fosamprenavir regimen (1400mg/100mg QD) to a 200mg ritonavir-boosted fosamprenavir regimen administered either twice-daily or once-daily.
Primary Outcome
Virologic failure was defined as two consecutive plasma HIV-1 RNA measures greater than 400 copies/milliliter (mL) separated by at least 2 to 4 week. The percentage of participants not meeting the virologic failure definition was estimated with stratification by the six randomization strata using Mantel-Haenszel weights and the missing/discontinuation equals failure (MD=F) analysis. Missing/discontinuation values were considered failures.
Interventions
- DRUG Half-boosted Fosamprenavir
- DRUG Full Boosted Fosamprenavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2006-05 |
| Est. Completion | 2008-06 |
| Phase | Phase 3 |
What the finished NCT00363142 record still lists
NCT00363142 is an interventional study that assigns participants to a tested intervention. The registered 211 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Half-boosted Fosamprenavir is the first listed.
NCT00363142 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00363142 about?
NCT00363142 is a clinical study titled "A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects". This is a 24-week study to evaluate the efficacy and safety of a once-daily ritonavir-boosted fosamprenavir regimen (1400mg/100mg QD) to a 200mg ritonavir-boosted fosamprenavir regimen administered either twice-daily or once-daily.
What is the current status of trial NCT00363142?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 211 participants. The study started on 2006-05. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00363142?
The interventions under investigation include: Half-boosted Fosamprenavir (DRUG), Full Boosted Fosamprenavir (DRUG).
Who is sponsoring clinical trial NCT00363142?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00363142's enrollment target sits among peer trials
211 1337th of 2000 higher than 663 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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