At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 113 enrolled
Drug / intervention
Raltegravir +1 moredrug
Likely dose
Raltegravir 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Efficacy and Safety Trial of Raltegravir Plus Darunavir/Ritonavir for Treatment-Naive HIV-1-Infected Subjects
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·interventional·Posted Jan 28, 2009·Updated Nov 8, 2018
In Brief
A Phase 2 clinical trial evaluating Raltegravir and Darunavir/Ritonavir for HIV-1 Infections. Completed, enrolled 113 participants across 22 sites.
Detailed Summary
The purpose of this study is to assess the effectiveness and safety of an antiretroviral therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as first-line therapy in treatment-naïve participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infections
CountriesUnited States
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2009
Enrollment StartApr 2009
Primary CompletionFeb 2010
Study CompletionSep 2010
TodayJul 2026
First PostedJan 28, 2009
Enrollment StartApr 1, 2009
Primary CompletionFeb 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.4 years ago
Interventions
Raltegravirdrug
400 mg tablet taken orally twice daily
Darunavir/Ritonavirdrug
800 mg Darunavir/100 mg Ritonavir tablet taken orally once daily