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NCT00071760 · ClinicalTrials.gov registry record · Phase 2
Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects
A Phase 2 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT00071760: Completed Phase 2 study, sponsored by ViiV Healthcare.
NCT00071760 is a Phase 2 study that has completed, run by ViiV Healthcare. The registered enrollment target is 59 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00071760, a Phase 2 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study Summary
This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to \< 2 years old.
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
Interventions
- DRUG ritonavir
- DRUG GW433908
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2003-10-23 |
| Est. Completion | 2022-03-29 |
| Phase | Phase 2 |
What the finished NCT00071760 record still lists
NCT00071760 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 2 interventions - of which ritonavir is the first listed.
NCT00071760 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00071760 about?
NCT00071760 is a clinical study titled "Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects". This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to \< 2 years old.
What is the current status of trial NCT00071760?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2003-10-23. Estimated completion is 2022-03-29.
What interventions are being tested in trial NCT00071760?
The interventions under investigation include: ritonavir (DRUG), GW433908 (DRUG).
Who is sponsoring clinical trial NCT00071760?
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 NCT00071760's enrollment target sits among peer trials
59 1133rd of 2000 higher than 866 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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