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A Pilot, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Raltegravir Versus NRTIs as a Backbone in HIV-Infected Patients Switched From a Stable Boosted PI Regimen
The purpose of this study is to determine whether raltegravir 400 mg b.i.d. in a boosted PI regimen is as efficacious and safe as the NRTI backbone in a boosted PI regimen.
Details
| Lead sponsor | University of South Florida |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 46 |
| Start date | 2008-11 |
| Completion | 2011-07 |
Conditions
- Virus Diseases
- HIV
Interventions
- Switch NRTIs as a Backbone to Raltegravir
Primary outcomes
- Number of Patients With Suppressed Viral Load(<75 Copies/ml)in Raltegravir 400 mg Bid vs. NRTI Backbone, Each in Combination of Boosted PI Regimen — at 24weeks for each patient
Number of patients with virologic suppression\< 75 copies/ ml at 24 wk,in raltegravir 400 mg bid vs. NRTI backbone, each in combination of boosted PI regimen.
Countries
United States