A Comparison of Two Tests for Anti-HIV Drug Resistance
HIV-1 Resistance Testing During Antiretroviral Failure: Comparison of Sequencing Versus Phenotyping
2 other identifiers
observational
600
2 countries
47
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedSeptember 25, 2008
July 1, 2004
November 8, 2000
September 24, 2008
Conditions
Keywords
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Willow Clinic
Menlo Park, California, 94025, United States
University of California San Francisco
San Francisco, California, 941104206, United States
Univ of California San Francisco
San Francisco, California, 94110, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107, United States
Stanford Univ Med Ctr
Stanford, California, 943055107, United States
Harbor UCLA Med Ctr
Torrance, California, 90502, United States
Denver Dept of Health and Hosps
Denver, Colorado, 80262, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Emory Univ
Atlanta, Georgia, 30308, United States
Univ of Hawaii
Honolulu, Hawaii, 96816, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
The CORE Ctr
Chicago, Illinois, 60612, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215, United States
Brigham and Women's Hosp
Boston, Massachusetts, 02215, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Cornell Clinical Trials Unit - Chelsea Clinic
New York, New York, 10011, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228, United States
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, 19104, United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Brown Univ / Miriam Hosp
Providence, Rhode Island, 02906, United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203, United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390, United States
Univ of Washington
Seattle, Washington, 98104, United States
Univ of Puerto Rico
San Juan, 009365067, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Richard D'Aquila
- STUDY CHAIR
Daniel Kuritzkes