CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 517 enrolled
Drug / intervention
Enfuvirtide +5 moredrug
Likely dose
Enfuvirtide 90mgfrom 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/NCT00537394
NCT00537394Phase 3Completed

The Optimized Treatment That Includes or Omits NRTIs Trial: A Randomized Strategy Study for HIV-1-Infected Treatment-Experienced Subjects Using the cPSS to Select an Effective Regimen

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Oct 1, 2007·Updated Nov 4, 2021

In Brief

A Phase 3 clinical trial evaluating Enfuvirtide, Raltegravir, and 4 other interventions for HIV Infections. Completed, enrolled 517 participants across 64 sites in 2 countries.

Detailed Summary

The goal of anti-HIV therapy is to prevent HIV from replicating. Long-term control of HIV requires at least two anti-HIV drugs that are active against the virus. Drug resistance is a problem for many treatment-experienced, HIV-infected people. The purpose of this study was to determine the benefit of adding a nucleoside reverse transcriptase inhibitor (NRTI) to a new anti-HIV drug regimen for the suppression of HIV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesPuerto Rico, United States

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 1, 2007
Enrollment StartJan 1, 2008
Primary CompletionMay 1, 2012
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 18.8 years ago

Interventions

Enfuvirtidedrug

90mg subcutaneously twice daily

Raltegravirdrug

400 mg twice daily

Darunavirdrug

Two 300-mg tablets twice daily, given with ritonavir 100mg twice daily (ritonavir not provided by the study)

Tipranavirdrug

Two 250-mg capsules twice daily, given with ritonavir 100mg twice daily (ritonavir not provided by the study)

Etravirinedrug

Two 100-mg tablets twice daily

Maravirocdrug

Dosage dependent on regimen in which maraviroc is included