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Clinical Trials
NCT00006490

A Comparison of Two Tests for Anti-HIV Drug Resistance

Last Updated: 2008-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Keywords

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HIV-1 Drug Resistance, Microbial Sequence Analysis, DNA Microbial Sensitivity Tests Genotype Phenotype Anti-HIV Agents

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

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Richard D'Aquila

Role: STUDY_CHAIR

Daniel Kuritzkes

Role: STUDY_CHAIR

Locations

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Univ of Alabama at Birmingham

Birmingham, Alabama, United States

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Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, United States

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UCLA CARE Ctr

Los Angeles, California, United States

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Willow Clinic

Menlo Park, California, United States

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University of California San Francisco

San Francisco, California, United States

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Univ of California San Francisco

San Francisco, California, United States

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Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium

San Jose, California, United States

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San Mateo AIDS Program / Stanford Univ

Stanford, California, United States

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Stanford Univ Med Ctr

Stanford, California, United States

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Harbor UCLA Med Ctr

Torrance, California, United States

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Denver Dept of Health and Hosps

Denver, Colorado, United States

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Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States

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Univ of Miami School of Medicine

Miami, Florida, United States

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Emory Univ

Atlanta, Georgia, United States

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Univ of Hawaii

Honolulu, Hawaii, United States

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Northwestern Univ Med School

Chicago, Illinois, United States

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Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

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The CORE Ctr

Chicago, Illinois, United States

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Johns Hopkins Hosp

Baltimore, Maryland, United States

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Harvard (Massachusetts Gen Hosp)

Boston, Massachusetts, United States

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Beth Israel Deaconess - West Campus

Boston, Massachusetts, United States

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Brigham and Women's Hosp

Boston, Massachusetts, United States

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