Clinical trialNCT00537394CompletedPhase 3Interventional

Optimizing Treatment for Treatment-Experienced, HIV-Infected People

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment517HIV Infections

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Karen T. Tashima, MD
Brown University
Study Chair
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Richard H. Haubrich, MD
Division of Infectious Diseases, UCSD Antiviral Research Center
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

64 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico

Puerto Rico Aids Clinical Trials Unit Crs
San Juan, Puerto Rico
San Juan City Hosp. Pr Nichd Crs
San Juan, Puerto Rico
University of Puerto Rico Pediatric Hiv/aids Research Program Crs
San Juan, Puerto Rico

United States

Alabama Therapeutics Crs
Birmingham, Alabama, United States
Miller Children'S Hosp. Long Beach Ca Nichd Crs
Long Beach, California, United States
Ucla Care Center Crs
Los Angeles, California, United States
Ucla-Los Angeles/brazil Aids Consortium (labac) Crs
Los Angeles, California, United States
University of Southern California Crs
Los Angeles, California, United States
Usc la Nichd Crs
Los Angeles, California, United States
Stanford Aids Clinical Trials Unit Crs
Palo Alto, California, United States
Ucsd Antiviral Research Center Crs
San Diego, California, United States
Ucsf Hiv/aids Crs
San Francisco, California, United States
Univ. of California San Francisco Nichd Crs
San Francisco, California, United States
University of Colorado Hospital Crs
Aurora, Colorado, United States
Denver Public Health Crs
Denver, Colorado, United States
Children'S National Med. Ctr. Atn Crs
Washington D.C., District of Columbia, United States
Georgetown University Crs (gu Crs)
Washington D.C., District of Columbia, United States
Howard Univ. Washington Dc Nichd Crs
Washington D.C., District of Columbia, United States
Pediatric Perinatal Hiv Clinical Trials Unit Crs
Miami, Florida, United States
the Ponce de Leon Center Crs
Atlanta, Georgia, United States
Northwestern University Crs
Chicago, Illinois, United States
Rush University Crs
Chicago, Illinois, United States
Tulane Univ. New Orleans Nichd Crs
New Orleans, Louisiana, United States
Ihv Baltimore Treatment Crs
Baltimore, Maryland, United States
Johns Hopkins University Crs
Baltimore, Maryland, United States
Beth Israel Deaconess Med. Ctr., Actg Crs
Boston, Massachusetts, United States
Bmc Actg Crs
Boston, Massachusetts, United States
Boston Medical Center Ped. Hiv Program Nichd Crs
Boston, Massachusetts, United States
Brigham and Women'S Hospital Therapeutics Clinical Research Site (bwh Tcrs) Crs
Boston, Massachusetts, United States
Massachusetts General Hospital Crs (mgh Crs)
Boston, Massachusetts, United States
Henry Ford Hosp. Crs
Detroit, Michigan, United States
Wayne State Univ. Crs
Detroit, Michigan, United States
Washington University Therapeutics (wt) Crs
St Louis, Missouri, United States
Cooper Univ. Hosp. Crs
Camden, New Jersey, United States
New Jersey Medical School Clinical Research Center Crs
Newark, New Jersey, United States
Rutgers - New Jersey Medical School Crs
Newark, New Jersey, United States
Columbia Impaact Crs
New York, New York, United States
Columbia P&s Crs
New York, New York, United States
Harlem Actg Crs
New York, New York, United States
Metropolitan Hosp. Nichd Crs
New York, New York, United States

24 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

DarunavirEnfuvirtideEtravirineMaravirocRaltegravirTipranavir

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Jan 2008
Primary completion: 31 May 2012
Completion: 30 Apr 2013
Last update posted: 4 Nov 2021
Registered enrollment: 517
Registry id: NCT00537394

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.