A Comparison of Two Tests for Anti-HIV Drug Resistance

Completed

• Conditions: HIV Infections

• Registration Number: NCT00006490
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2000-11-08
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2004-07
• Last Update Submitted: 2008-09-24
• Last Update Posted: 2008-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (47)

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

Scroll for more (37 remaining)