A Comparison of Two Tests for Anti-HIV Drug Resistance

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

Patrocinadores

Patrocinador principal: National Institute of Allergy and Infectious Diseases (NIAID)

Fuente National Institute of Allergy and Infectious Diseases (NIAID)
Resumen breve

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.

Descripción detallada

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.

Estado general Completed
Tipo de estudio Observational
Inscripción 600
Condición
Elegibilidad

Criterios:

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.

Género: All

Edad mínima: 14 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Ubicación
Instalaciones:
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
Ubicacion Paises

Puerto Rico

United States

Fecha de verificación

July 2004

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Fuente: ClinicalTrials.gov