CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
Switch NRTIs as a Backbone to Raltegravirdrug
Likely dose
Not stated in 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.

Search/NCT00749580
NCT00749580N/ACompleted
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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

University of South Florida·interventional·Posted Sep 9, 2008·Updated Dec 17, 2014

In Brief

A clinical study evaluating Switch NRTIs as a Backbone to Raltegravir for Virus Diseases and HIV. Completed, enrolled 46 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVirus Diseases, HIV
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC, St. Joseph's Hospital, Florida

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2008
Enrollment StartNov 1, 2008
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.8 years ago

Interventions

Switch NRTIs as a Backbone to Raltegravirdrug

This is a multicenter, pilot randomized, controlled study to evaluate the safety and efficacy of raltegravir in patients switched from a stable boosted PI-based regimen with a NRTI backbone to raltegravir instead of their current NRTIs. A stable boosted PI-based regimen is defined as having a documented HIV RNA \<75 copies/mL for ≥ 3 months prior to study entry, while receiving a boosted PI-based with NRTI backbone. Additionally, patients must not have had HIV RNA ≥ 75 copies/mL during the three months prior to study entry. Approximately 25 patients will be enrolled in the raltegravir treatment arm (Group 1) and approximately 25 patients in the continuation of the current NRTI backbone regimen treatment arm (Group 2). Patients will be randomly assigned 1:1 to a treatment group.