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NCT00708162 · ClinicalTrials.gov registry record · Phase 3
Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 724
- Enrollment target
NCT00708162: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT00708162 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 724 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00708162, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 724 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the safety, tolerability and efficacy of a regimen containing once-daily elvitegravir (EVG) versus twice-daily raltegravir (RAL) added to a background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional antiretroviral (ARV) agents) in HIV-1 infected, ARV treatment-experienced adults who have documented resistance, or at least six months experience prior to screening with two or more different classes of ARV agents. Participants will be randomized in a 1:1 ratio to receive EVG plus background regimen (Elvitegravir group), or raltegravir plus background regimen (Raltegravir group). Due to known drug interactions, participants in the Elvitegravir group receiving RTV-boosted atazanavir (ATV) or RTV-boosted lopinavir (LPV) as part of their background regimen will receive elvitegravir at a lower dose (85 mg).
Primary Outcome
The percentage of participants achieving and maintaining confirmed HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the FDA-defined Time to Loss of Virologic Response (TLOVR) algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.
Interventions
- DRUG Raltegravir
- DRUG Elvitegravir
- DRUG EVG placebo
- DRUG RAL placebo
- DRUG Background regimen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 724 participants |
| Start Date | 2008-07 |
| Est. Completion | 2015-04 |
| Phase | Phase 3 |
What the finished NCT00708162 record still lists
NCT00708162 is an interventional study that assigns participants to a tested intervention. The registered 724 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Raltegravir is the first listed.
NCT00708162 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00708162 about?
NCT00708162 is a clinical study titled "Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir". The purpose of this study is to compare the safety, tolerability and efficacy of a regimen containing once-daily elvitegravir (EVG) versus twice-daily raltegravir (RAL) added to a background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional antiretroviral...
What is the current status of trial NCT00708162?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 724 participants. The study started on 2008-07. Estimated completion is 2015-04.
What interventions are being tested in trial NCT00708162?
The interventions under investigation include: Raltegravir (DRUG), Elvitegravir (DRUG), EVG placebo (DRUG), RAL placebo (DRUG), Background regimen (DRUG).
Who is sponsoring clinical trial NCT00708162?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00708162's enrollment target sits among peer trials
724 491st of 2000 higher than 1,509 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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