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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 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 724 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00708162
The ClinicalTrials.gov registry entry for NCT00708162 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 724 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Raltegravir is the first listed.
NCT00708162 reports 0 study locations.
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.
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