A Comparison of Two Tests for Anti-HIV Drug Resistance

Completed

Conditions studied: HIV Infections

In brief

The purpose of this study is to compare 2 different types of tests of the HIV virus to see which specific anti-HIV drugs would work the best. Drug resistance is a major reason for therapy failure in HIV patients. Two types of tests can detect resistance to drugs: 1) genotyping (sequencing), which looks at the DNA sequence of a virus to see whether it has developed any genetic resistance; 2) phenotyping, which looks at the ability of different drugs to suppress virus growth in the laboratory. Genotyping and phenotyping can help doctors give patients the most effective drug therapy.

Key facts

Study ID: NCT00006490
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 600
Last updated by the study team: 2008-09-25

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients may be eligible for this study if they:
Are HIV-positive.
Have failed 2 to 4 anti-HIV regimens containing 3 or more combinations of drugs. A patient has failed his/her current regimen if he/she has, within 30 days of study entry, either a viral load (level of HIV in the blood) of at least 10,000 copies/ml or 2 tests which show a viral load between 1,000 and 10,000 copies/ml.
Have taken 3 or more anti-HIV drugs for 8 or more weeks before the study.
Are at least 14 years old.
Have consent of parent or guardian if less than 18 years old.

You may not qualify if…

Patients will not be eligible for this study if they:
Have failed only 1 anti-HIV drug combination.
Have failed 5 or more anti-HIV drug combinations, each containing 3 to 5 drugs.
Have had and received the results of prior resistance tests.
Have had treatment with a combination of 6 or more anti-HIV drugs.
Have problems absorbing food in the intestine.
Have had HIV vaccines.
Have taken drugs that affect the immune system or investigational drugs.
Are taking medications not allowed with protease inhibitors (PIs) if PIs would be part of their anti-HIV treatment during the study.
Have failed anti-HIV therapy due to nonadherence to medication.

Where it is running

Univ of Alabama at Birmingham — Birmingham, Alabama, United States
Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
UCLA CARE Ctr — Los Angeles, California, United States
Willow Clinic — Menlo Park, California, United States
University of California San Francisco — San Francisco, California, United States
Univ of California San Francisco — San Francisco, California, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium — San Jose, California, United States
San Mateo AIDS Program / Stanford Univ — Stanford, California, United States
Stanford Univ Med Ctr — Stanford, California, United States
Harbor UCLA Med Ctr — Torrance, California, United States
Denver Dept of Health and Hosps — Denver, Colorado, United States
Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
Univ of Miami School of Medicine — Miami, Florida, United States
Emory Univ — Atlanta, Georgia, United States
Univ of Hawaii — Honolulu, Hawaii, United States
Northwestern Univ Med School — Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
The CORE Ctr — Chicago, Illinois, United States
Johns Hopkins Hosp — Baltimore, Maryland, United States
Harvard (Massachusetts Gen Hosp) — Boston, Massachusetts, United States
Beth Israel Deaconess - West Campus — Boston, Massachusetts, United States
Brigham and Women's Hosp — Boston, Massachusetts, United States
SUNY / Erie County Med Ctr at Buffalo — Buffalo, New York, United States
Beth Israel Med Ctr — New York, New York, United States
Cornell Clinical Trials Unit - Chelsea Clinic — New York, New York, United States

Full record on ClinicalTrials.gov

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