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Completed Phase 3 Interventional Results available

Optimizing Treatment for Treatment-Experienced, HIV-Infected People

ClinicalTrials.gov ID: NCT00537394

Public ClinicalTrials.gov record NCT00537394. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 8:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00537394
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
517 participants

Conditions and interventions

Eligibility (public fields only)

Age range
16 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2007
Primary completion
Apr 30, 2012
Completion
Mar 31, 2013
Last update posted
Nov 3, 2021

2008 – 2013

United States locations

U.S. sites
61
U.S. states
23
U.S. cities
37
Facility City State ZIP Site status
Alabama Therapeutics CRS Birmingham Alabama 35294-2050
Miller Children's Hosp. Long Beach CA NICHD CRS Long Beach California 90806
University of Southern California CRS Los Angeles California 90033
Usc La Nichd Crs Los Angeles California 90033
UCLA CARE Center CRS Los Angeles California 90035
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS Los Angeles California 90095-1752
Stanford AIDS Clinical Trials Unit CRS Palo Alto California 94304-5350
UCSD Antiviral Research Center CRS San Diego California 92103
Ucsf Hiv/Aids Crs San Francisco California 94110
Univ. of California San Francisco NICHD CRS San Francisco California 94143
University of Colorado Hospital CRS Aurora Colorado 80045
Denver Public Health CRS Denver Colorado 80204
Georgetown University CRS (GU CRS) Washington D.C. District of Columbia 20007
Children's National Med. Ctr. ATN CRS Washington D.C. District of Columbia 20010
Howard Univ. Washington DC NICHD CRS Washington D.C. District of Columbia 20060
Pediatric Perinatal HIV Clinical Trials Unit CRS Miami Florida 33136
The Ponce de Leon Center CRS Atlanta Georgia 30308-2012
Northwestern University CRS Chicago Illinois 60611
Rush University CRS Chicago Illinois 60612
Tulane Univ. New Orleans NICHD CRS New Orleans Louisiana 70112-2699
IHV Baltimore Treatment CRS Baltimore Maryland 21201
Johns Hopkins University CRS Baltimore Maryland 21205
Massachusetts General Hospital CRS (MGH CRS) Boston Massachusetts 02114
Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS Boston Massachusetts 02115
Bmc Actg Crs Boston Massachusetts 02118
Boston Medical Center Ped. HIV Program NICHD CRS Boston Massachusetts 02118
Beth Israel Deaconess Med. Ctr., ACTG CRS Boston Massachusetts 02215
Wayne State Univ. CRS Detroit Michigan 48201
Henry Ford Hosp. CRS Detroit Michigan 48202
Washington University Therapeutics (WT) CRS St Louis Missouri 63110
Cooper Univ. Hosp. CRS Camden New Jersey 08103
New Jersey Medical School Clinical Research Center CRS Newark New Jersey 07103
Rutgers - New Jersey Medical School CRS Newark New Jersey 07103
Weill Cornell Chelsea CRS New York New York 10011
NY Univ. HIV/AIDS CRS New York New York 10016
Nyu Ny Nichd Crs New York New York 10016
Metropolitan Hosp. NICHD CRS New York New York 10029
Columbia P&S CRS New York New York 10032-3732
Columbia IMPAACT CRS New York New York 10032
Harlem ACTG CRS New York New York 10037
Trillium Health ACTG CRS Rochester New York 14607
Univ. of Rochester ACTG CRS Rochester New York 14642
Bronx-Lebanon Hosp. Ctr. CRS The Bronx New York 10457
Chapel Hill CRS Chapel Hill North Carolina 27514
Duke Univ. Med. Ctr. Adult CRS Durham North Carolina 27710
Cincinnati CRS Cincinnati Ohio 45267-0405
Case Clinical Research Site Cleveland Ohio 44106
MetroHealth CRS Cleveland Ohio 44109
Ohio State University CRS Columbus Ohio 43210
The Research & Education Group-Portland CRS Portland Oregon 97210
Penn Therapeutics, CRS Philadelphia Pennsylvania 19104
Thomas Jefferson Univ. Med. Ctr. CRS Philadelphia Pennsylvania 19107
University of Pittsburgh CRS Pittsburgh Pennsylvania 15213-2582
The Miriam Hospital Clinical Research Site (TMH CRS) CRS Providence Rhode Island 02906
St. Jude Children's Research Hospital CRS Memphis Tennessee 38105
Vanderbilt Therapeutics (VT) CRS Nashville Tennessee 37204
Trinity Health and Wellness Center CRS Dallas Texas 75208
Houston AIDS Research Team CRS Houston Texas 77030
Texas Children's Hospital CRS Houston Texas 77030
Virginia Commonwealth Univ. Medical Ctr. CRS Richmond Virginia 23298
University of Washington AIDS CRS Seattle Washington 98104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00537394, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 3, 2021 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00537394 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →