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Optimizing Treatment for Treatment-Experienced, HIV-Infected People

NCT00537394 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 517

Last updated 2021-11-04

Study results available
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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.

Conditions

  • HIV Infections

Interventions

DRUG

Enfuvirtide

90mg subcutaneously twice daily

DRUG

Raltegravir

400 mg twice daily

DRUG

Darunavir

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

DRUG

Tipranavir

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

DRUG

Etravirine

Two 100-mg tablets twice daily

DRUG

Maraviroc

Dosage dependent on regimen in which maraviroc is included

Sponsors & Collaborators

  • Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Karen T. Tashima, MD · Brown University

  • Richard H. Haubrich, MD · Division of Infectious Diseases, UCSD Antiviral Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2012-05-31
Completion
2013-04-30

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00537394 on ClinicalTrials.gov