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Clinical trialNCT00041769CompletedPhase 3Interventional

Using Drug Levels in the Blood to Guide Therapy in HIV Infected Patients Taking a Protease Inhibitor

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment360HIV Infections
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Drug resistance testing can be used to see which anti-HIV drugs are likely to suppress the growth of HIV and to select an anti-HIV regimen for HIV infected patients who have failed previous drug regimens. Therapeutic drug monitoring (TDM) is a process that involves measuring blood levels of a drug and may further increase the benefits that resistance testing offers by optimizing protease inhibitor (PI) drug concentrations. The purpose of this study is to determine whether changing the dose of PIs, as indicated by TDM, reduces the viral load in PI-experienced patients. Hypothesis: Treatment-naive study participants who undergo TDM and whose clinicians' interpret their TDM results and adjust their PI doses will have better virologic response rates and decreased toxicities (and thus better treatment outcomes) than participants who do not undergo TDM.
clinicaltrials.gov ↗

Investigators

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

  • Lisa Demeter, MD

    Infectious Diseases Unit, University of Rochester Medical Center

    Study Chair
    clinicaltrials.gov ↗
  • Mary Albrecht, MD

    Division of Infectious Diseases, Beth Israel Deaconess Medical Center

    Study Chair
    clinicaltrials.gov ↗

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

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

Puerto Rico
  • University of Puerto Rico

    San Juan, Puerto Rico

United States
  • Univ of Alabama at Birmingham

    Birmingham, Alabama, United States

  • Ucla School of Medicine

    Los Angeles, California, United States

  • Univ of Southern California

    Los Angeles, California, United States

  • Univ of California, San Diego Antiviral Research Center (avrc)

    San Diego, California, United States

  • Univ of California San Francisco

    San Francisco, California, United States

  • San Mateo County Aids Program

    Stanford, California, United States

  • Santa Clara Valley Med Ctr

    Stanford, California, United States

  • Willow Clinic

    Stanford, California, United States

  • Univ of Colorado Health Sciences Ctr

    Denver, Colorado, United States

  • Univ of Miami

    Miami, Florida, United States

  • Univ of Hawaii

    Honolulu, Hawaii, United States

  • Northwestern Univ

    Chicago, Illinois, United States

  • the Core Ctr

    Chicago, Illinois, United States

  • Indiana Univ Hosp

    Indianapolis, Indiana, United States

  • Methodist Hosp of Indiana

    Indianapolis, Indiana, United States

  • Wishard Hosp

    Indianapolis, Indiana, United States

  • Johns Hopkins Univ

    Baltimore, Maryland, United States

  • Univ of Maryland, Institute of Human Virology

    Baltimore, Maryland, United States

  • Beth Israel Deaconess-West Campus

    Boston, Massachusetts, United States

  • Brigham and Women'S Hosp

    Boston, Massachusetts, United States

  • Harvard (masschusetts General Hosp)

    Boston, Massachusetts, United States

  • Univ of Minnesota

    Minneapolis, Minnesota, United States

  • St. Louis Connect Care

    St Louis, Missouri, United States

  • Washington Univ (st. Louis)

    St Louis, Missouri, United States

  • Suny-Buffalo (rochester)

    Buffalo, New York, United States

  • Beth Israel Medical Center

    New York, New York, United States

  • Chelsea Clinic

    New York, New York, United States

  • Columbia Univ

    New York, New York, United States

  • Long Beach Memorial (pediatric)

    New York, New York, United States

  • New York University - Bellevue

    New York, New York, United States

  • Community Health Network Inc

    Rochester, New York, United States

  • Univ of Rochester Medical Center

    Rochester, New York, United States

  • University of North Carolina

    Chapel Hill, North Carolina, United States

  • Duke Univ Med Ctr

    Durham, North Carolina, United States

  • Ohio State Univ

    Cincinnati, Ohio, United States

  • Univ of Cincinnati

    Cincinnati, Ohio, United States

  • Case Western Reserve Univ

    Cleveland, Ohio, United States

  • Cleveland Clinic

    Cleveland, Ohio, United States

  • Metrohealth Med Ctr

    Cleveland, Ohio, United States

7 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

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

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

Start
30 Jun 2002
Primary completion
30 Apr 2007
Completion
31 Aug 2007
Last update posted
13 Jul 2010
Registered enrollment
360
Registry id
NCT00041769
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.