- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00006490
A Comparison of Two Tests for Anti-HIV Drug Resistance
HIV-1 Resistance Testing During Antiretroviral Failure: Comparison of Sequencing Versus Phenotyping
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 general del estudio
Estado
Condiciones
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.
Tipo de estudio
Inscripción
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- Univ of Alabama at Birmingham
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California
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Los Angeles, California, Estados Unidos, 90095
- UCLA CARE Ctr
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Los Angeles, California, Estados Unidos, 900331079
- Univ of Southern California / LA County USC Med Ctr
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Menlo Park, California, Estados Unidos, 94025
- Willow Clinic
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San Francisco, California, Estados Unidos, 94110
- Univ of California San Francisco
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San Francisco, California, Estados Unidos, 941104206
- University of California San Francisco
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San Jose, California, Estados Unidos, 951282699
- Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
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Stanford, California, Estados Unidos, 943055107
- San Mateo AIDS Program / Stanford Univ
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Stanford, California, Estados Unidos, 943055107
- Stanford Univ Med Ctr
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Torrance, California, Estados Unidos, 90502
- Harbor UCLA Med Ctr
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Colorado
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Denver, Colorado, Estados Unidos, 80262
- Univ of Colorado Health Sciences Ctr
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Denver, Colorado, Estados Unidos, 80262
- Denver Dept of Health and Hosps
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Florida
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Miami, Florida, Estados Unidos, 331361013
- Univ of Miami School of Medicine
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Georgia
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Atlanta, Georgia, Estados Unidos, 30308
- Emory Univ
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96816
- Univ of Hawaii
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- The CORE Ctr
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern Univ Med School
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Chicago, Illinois, Estados Unidos, 60612
- Rush Presbyterian - Saint Luke's Med Ctr
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins Hosp
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Harvard (Massachusetts Gen Hosp)
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Boston, Massachusetts, Estados Unidos, 02215
- Beth Israel Deaconess - West Campus
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Boston, Massachusetts, Estados Unidos, 02215
- Brigham and Women's Hosp
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New York
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Buffalo, New York, Estados Unidos, 14215
- SUNY / Erie County Med Ctr at Buffalo
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New York, New York, Estados Unidos, 10003
- Beth Israel Med Ctr
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New York, New York, Estados Unidos, 10021
- Cornell Univ Med Ctr
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New York, New York, Estados Unidos, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, Estados Unidos, 10029
- Mount Sinai Med Ctr
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New York, New York, Estados Unidos, 10032
- Columbia Presbyterian Med Ctr
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New York, New York, Estados Unidos, 10011
- Cornell Clinical Trials Unit - Chelsea Clinic
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 275997215
- Univ of North Carolina
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Charlotte, North Carolina, Estados Unidos, 28203
- Carolinas Med Ctr
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Durham, North Carolina, Estados Unidos, 27710
- Duke Univ Med Ctr
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Greensboro, North Carolina, Estados Unidos, 27401
- Moses H Cone Memorial Hosp
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Ohio
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Cincinnati, Ohio, Estados Unidos, 452670405
- Univ of Cincinnati
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Cleveland, Ohio, Estados Unidos, 44106
- Case Western Reserve Univ
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Cleveland, Ohio, Estados Unidos, 441091998
- MetroHealth Med Ctr
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Columbus, Ohio, Estados Unidos, 432101228
- Ohio State Univ Hosp Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Univ of Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Philadelphia Veterans Administration Med Ctr
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Univ of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02906
- Brown Univ / Miriam Hosp
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Providence, Rhode Island, Estados Unidos, 02906
- Miriam Hosp / Brown Univ
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South Carolina
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West Columbia, South Carolina, Estados Unidos, 29169
- Julio Arroyo
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Vanderbilt Univ Med Ctr
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Texas
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Dallas, Texas, Estados Unidos, 75390
- Univ of Texas, Southwestern Med Ctr of Dallas
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Washington
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Seattle, Washington, Estados Unidos, 98104
- Univ of Washington
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San Juan, Puerto Rico, 009365067
- Univ of Puerto Rico
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Colaboradores e Investigadores
Investigadores
- Silla de estudio: Richard D'Aquila
- Silla de estudio: Daniel Kuritzkes
Fechas de registro del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Infecciones por VIH
Otros números de identificación del estudio
- ACTG A5076
- AACTG A5076
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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