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NCT00089583 · ClinicalTrials.gov registry record · Phase 2
48-Week Study Of GW433908 And Ritonavir Or GW433908 Alone, Twice Daily In Pediatric Patients With HIV Infection
A Phase 2 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
NCT00089583: Completed Phase 2 study, sponsored by ViiV Healthcare.
NCT00089583 is a Phase 2 study that has completed, run by ViiV Healthcare. The registered enrollment target is 110 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00089583, a Phase 2 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
Study Summary
This is a 48-week study to collect information on the safety and activity of an investigational medicine in patients, ages 2 to 18 years old, with HIV infection .
Primary Outcome
Plasma samples were assayed for APV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma APV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC\[0-τ\]), where τ is the length of the dosing interval, was calculated by the li
Interventions
- DRUG Ritonavir
- DRUG LEXIVA (GW433908)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2004-07 |
| Est. Completion | 2013-07 |
| Phase | Phase 2 |
What the finished NCT00089583 record still lists
NCT00089583 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Ritonavir is the first listed.
NCT00089583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00089583 about?
NCT00089583 is a clinical study titled "48-Week Study Of GW433908 And Ritonavir Or GW433908 Alone, Twice Daily In Pediatric Patients With HIV Infection". This is a 48-week study to collect information on the safety and activity of an investigational medicine in patients, ages 2 to 18 years old, with HIV infection .
What is the current status of trial NCT00089583?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2004-07. Estimated completion is 2013-07.
What interventions are being tested in trial NCT00089583?
The interventions under investigation include: Ritonavir (DRUG), LEXIVA (GW433908) (DRUG).
Who is sponsoring clinical trial NCT00089583?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00089583's enrollment target sits among peer trials
110 632nd of 2000 higher than 1,361 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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