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NCT00920426 · ClinicalTrials.gov registry record · Phase 2
Study to Compare the Safety and Anti-HIV Effect of GSK1265744 Versus Placebo in HIV-1 Infected Adults (ITZ112929)
A Phase 2 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT00920426: Completed Phase 2 study, sponsored by ViiV Healthcare.
NCT00920426 is a Phase 2 study that has completed, run by ViiV Healthcare. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00920426, a Phase 2 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
The purpose of this randomized, double-blinded study is to test the safety of GSK1265744 and how well it works on reducing the amount of HIV in the blood. It will also look at how people react to and how a human body uses GSK1265744. This study will compare the effects of GSK1265744 and placebo. The study will consist of 1 or 2 parts to look at doses of GSK1265744. About 8 people will take part in Part 1 of the study receiving dose A. If additional dosing information is needed after Part 1, about 6 people will take part in Part 2 of the study receiving dose B.
Primary Outcome
Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a lower limit of detection (LLOD) of 50 copies/milliliter (mL) (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test
Interventions
- DRUG Placebo
- DRUG GSK1265744 30mg
- DRUG GSK1265744 5mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2009-06-09 |
| Est. Completion | 2009-08-13 |
| Phase | Phase 2 |
What the finished NCT00920426 record still lists
NCT00920426 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00920426 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00920426 about?
NCT00920426 is a clinical study titled "Study to Compare the Safety and Anti-HIV Effect of GSK1265744 Versus Placebo in HIV-1 Infected Adults (ITZ112929)". The purpose of this randomized, double-blinded study is to test the safety of GSK1265744 and how well it works on reducing the amount of HIV in the blood. It will also look at how people react to and how a human body uses GSK1265744. This study will compare the effects of GSK1265744 and placebo. Th...
What is the current status of trial NCT00920426?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2009-06-09. Estimated completion is 2009-08-13.
What interventions are being tested in trial NCT00920426?
The interventions under investigation include: Placebo (DRUG), GSK1265744 30mg (DRUG), GSK1265744 5mg (DRUG).
Who is sponsoring clinical trial NCT00920426?
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 NCT00920426's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 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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