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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00041769

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

360

Starts

2002-06-01

Expected to finish

2007-08-01

Last updated by the study team

2010-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Growth factors, interleukins, interferons (except for the treatment of hepatitis C), non-FDA approved systemic drugs, and HIV vaccines within 30 days of study entry
• Require certain medications prior to or during the study
• Certain heart conditions, if starting a PI-based regimen as the salvage regimen
• Acute illness or infection requiring treatment within 14 days of study entry
• Any condition that would limit ability to participate in the study
• Cancer requiring radiation or systemic chemotherapy
• Active drug or alcohol use or dependence that would interfere with the ability to meet study requirements
• Acute or chronic pancreatitis
• Planned use of hydroxyurea in the salvage regimen
• Pregnant or breastfeeding

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Univ of Southern California — Los Angeles, California, United States
• UCLA School of Medicine — 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
• Methodist Hosp of Indiana — Indianapolis, Indiana, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Wishard Hosp — Indianapolis, Indiana, United States
• Univ of Maryland, Institute of Human Virology — Baltimore, Maryland, United States
• Johns Hopkins Univ — Baltimore, Maryland, United States
• Harvard (Masschusetts General Hosp) — Boston, Massachusetts, United States
• Beth Israel Deaconess-West Campus — Boston, Massachusetts, United States
• Brigham and Women's 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

Full record on ClinicalTrials.gov

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