A Comparison of Two Tests for Anti-HIV Drug Resistance

HIV Infections Clinical Trial

Official title:

HIV-1 Resistance Testing During Antiretroviral Failure: Comparison of Sequencing Versus Phenotyping

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006490
• Other study ID #: ACTG A5076
• Secondary ID: AACTG A5076
• Status: Completed
• Phase: N/A
• First received: November 8, 2000
• Last updated: September 24, 2008

Study information

• Verified date: July 2004
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Description:

The emergence of drug resistance is a major factor contributing to the failure of antiretroviral therapy in HIV-infected patients. Drug resistance can be detected by genotypic or phenotypic assays, both having distinct advantages and disadvantages. Results from genotypic and phenotypic testing are helpful in excluding from the subsequent regimen drugs to which the resistance is identified, and both tests predict virologic response to salvage therapy in patients who have failed a previous regimen. Resistance testing is likely to be beneficial as an aid in selecting a salvage regimen.

At entry, patients are randomized to Arm A (sequencing) or Arm B (phenotyping) and have a resistance test drawn while still receiving the current regimen even though regimen failure is suspected. The test results are available between Weeks 1 and 4, inclusive. There are weekly visits for the first 4 weeks after entry to monitor viral load and maintenance of the current failing (prestudy) regimen. If virologic failure is confirmed, a new regimen is chosen and prescribed at the first visit after resistance test results are available. [AS PER AMENDMENT 12/6/00: If the resistance assay fails to yield results, another regimen is chosen and prescribed based on the patient's medical and medication history.] If virologic failure is not confirmed, the current drug regimen is not changed. Otherwise, on-site study visits occur every 4 weeks until Week 24 and then every 8 weeks thereafter through Week 48. [AS PER AMENDMENT 12/6/00: on-site study visits occur every 4 weeks until Week 24 and then every 8 weeks thereafter]. Medical resource use is assessed at baseline and then every 8 weeks through Week 48. Quality of life is assessed at baseline and then every 16 weeks through Week 48.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Study Design

N/A

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Puerto Rico	Univ of Puerto Rico	San Juan
United States	Emory Univ	Atlanta	Georgia
United States	Johns Hopkins Hosp	Baltimore	Maryland
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess - West Campus	Boston	Massachusetts
United States	Brigham and Women's Hosp	Boston	Massachusetts
United States	Harvard (Massachusetts Gen Hosp)	Boston	Massachusetts
United States	SUNY / Erie County Med Ctr at Buffalo	Buffalo	New York
United States	Univ of North Carolina	Chapel Hill	North Carolina
United States	Carolinas Med Ctr	Charlotte	North Carolina
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	Univ of Cincinnati	Cincinnati	Ohio
United States	Case Western Reserve Univ	Cleveland	Ohio
United States	MetroHealth Med Ctr	Cleveland	Ohio
United States	Ohio State Univ Hosp Clinic	Columbus	Ohio
United States	Univ of Texas, Southwestern Med Ctr of Dallas	Dallas	Texas
United States	Denver Dept of Health and Hosps	Denver	Colorado
United States	Univ of Colorado Health Sciences Ctr	Denver	Colorado
United States	Duke Univ Med Ctr	Durham	North Carolina
United States	Moses H Cone Memorial Hosp	Greensboro	North Carolina
United States	Univ of Hawaii	Honolulu	Hawaii
United States	UCLA CARE Ctr	Los Angeles	California
United States	Univ of Southern California / LA County USC Med Ctr	Los Angeles	California
United States	Willow Clinic	Menlo Park	California
United States	Univ of Miami School of Medicine	Miami	Florida
United States	Vanderbilt Univ Med Ctr	Nashville	Tennessee
United States	Bellevue Hosp / New York Univ Med Ctr	New York	New York
United States	Beth Israel Med Ctr	New York	New York
United States	Columbia Presbyterian Med Ctr	New York	New York
United States	Cornell Clinical Trials Unit - Chelsea Clinic	New York	New York
United States	Cornell Univ Med Ctr	New York	New York
United States	Mount Sinai Med Ctr	New York	New York
United States	Philadelphia Veterans Administration Med Ctr	Philadelphia	Pennsylvania
United States	Univ of Pennsylvania	Philadelphia	Pennsylvania
United States	Univ of Pittsburgh	Pittsburgh	Pennsylvania
United States	Brown Univ / Miriam Hosp	Providence	Rhode Island
United States	Miriam Hosp / Brown Univ	Providence	Rhode Island
United States	Univ of California San Francisco	San Francisco	California
United States	University of California San Francisco	San Francisco	California
United States	Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium	San Jose	California
United States	Univ of Washington	Seattle	Washington
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	Julio Arroyo	West Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

External Links

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