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Effectiveness of the Early Addition of Abacavir to an Anti-HIV Drug Combination

8 de septiembre de 2008 actualizado por: National Institute of Allergy and Infectious Diseases (NIAID)

A Pilot Study of Early Treatment Intensification of Antiretroviral Therapy

The purpose of this study is to see if adding 1 drug to an anti-HIV drug combination early in treatment against HIV can lower the viral load (amount of HIV in the blood) to a level so low that it cannot be measured (undetectable). The drug that will be added to a treatment is abacavir (ABC).

Many patients who take 3 anti-HIV drugs together are able to achieve very low viral loads, for example, viral loads below 50 copies/ml. However, some patients taking only 3 drugs are not able to achieve a viral load this low. Doctors hope that, by adding the drug ABC to a current treatment, a viral load below 50 copies/ml can be achieved. Doctors would like to find out if it is effective to start patients on 3 drugs and then add another drug (treatment intensification) if the treatment is not working as well as hoped.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Combination antiretroviral therapy can offer patients potent suppression of HIV replication and improved immunologic functioning. However, despite aggressive antiretroviral regimens currently in use, only about 50 to 60 percent of patients attain plasma viral loads below 50 copies/ml after 24 weeks. Initiating treatment with a 4-drug regimen may increase this percentage, but this may also contribute to patient non-adherence, drug-related toxicities, potential cross-resistance to drugs used in future regimens, and high financial costs. Another strategy is early intensification (adding a single drug to an existing regimen) in patients who are at risk for attaining incomplete viral suppression after 24 weeks of therapy. ABC may produce a significant antiviral effect when used as an intensification agent in patients on a stable antiretroviral regimen. The results of this study will offer insight into the potential benefits of early treatment intensification.

Patients entering this study will have initiated potent antiretroviral therapy. Between 60 and 90 days [AS PER AMENDMENT 1/9/01: 60 and 104 days] after beginning their background regimen, patients are randomized to add either ABC (Arm A) or a matching placebo (Arm B) for 12 weeks. Patients completing 12 weeks of treatment continue on study for an additional 24 weeks to Week 36. Patients discontinue treatment if virologic failure occurs at any time. Patients still return to the clinic for HIV-1 RNA measurements at Weeks 12 and 36, depending on when discontinuation occurred. Patients who discontinue treatment at or after Week 12 due to virologic failure are offered open-label ABC for the remainder of the study (through Week 36). Blood samples are collected at Weeks 4, 8, 12, 20, 28, and 36. Plasma samples for population sequencing of HIV-1 PR and RT genes are collected on all patients at study entry and at the time of virologic failure. Baseline genotype (presence or absence of PR and RT resistance mutations and number of resistance mutations) is correlated to treatment outcome. Samples from the time of failure are analyzed for the accumulation of additional resistance mutations. [AS PER AMENDMENT 5/5/00: Patients and their primary care physicians will be unblinded to the patient's treatment after the study is completed at Week 36 or if virologic failure occurs at or after Week 12 [AS PER AMENDMENT 1/9/01: or if ABC hypersensitivity is suspected].]

Tipo de estudio

Intervencionista

Inscripción

80

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90095
        • UCLA CARE Ctr
      • Menlo Park, California, Estados Unidos, 94025
        • Willow Clinic
      • San Jose, California, Estados Unidos, 951282699
        • Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
      • Stanford, California, Estados Unidos, 943055107
        • San Mateo AIDS Program / Stanford Univ
      • Stanford, California, Estados Unidos, 943055107
        • Stanford Univ Med Ctr
      • Torrance, California, Estados Unidos, 90502
        • Harbor UCLA Med Ctr
    • Colorado
      • Denver, Colorado, Estados Unidos, 80262
        • Univ of Colorado Health Sciences Ctr
    • Florida
      • Miami, Florida, Estados Unidos, 331361013
        • Univ of Miami School of Medicine
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30308
        • Emory Univ
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Northwestern Univ Med School
      • Chicago, Illinois, Estados Unidos, 60612
        • Cook County Hosp
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21287
        • Johns Hopkins Hosp
      • Baltimore, Maryland, Estados Unidos, 212052196
        • State of MD Div of Corrections / Johns Hopkins Univ Hosp
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63112
        • St Louis Regional Hosp / St Louis Regional Med Ctr
    • New York
      • Buffalo, New York, Estados Unidos, 14215
        • SUNY / Erie County Med Ctr at Buffalo
      • New York, New York, Estados Unidos, 10003
        • Beth Israel Med Ctr
      • New York, New York, Estados Unidos, 10016
        • Bellevue Hosp / New York Univ Med Ctr
      • New York, New York, Estados Unidos, 10032
        • Columbia Presbyterian Med Ctr
      • New York, New York, Estados Unidos, 10021
        • Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
      • Rochester, New York, Estados Unidos, 14642
        • Univ of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 275997215
        • Univ of North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
        • Duke Univ Med Ctr
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 452670405
        • Univ of Cincinnati
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Univ of Pennsylvania at Philadelphia
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Philadelphia Veterans Administration Med Ctr
    • South Carolina
      • West Columbia, South Carolina, Estados Unidos, 29169
        • Julio Arroyo
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37203
        • Vanderbilt Univ Med Ctr
    • Texas
      • Dallas, Texas, Estados Unidos, 75390
        • Univ of Texas, Southwestern Med Ctr of Dallas
    • Washington
      • Seattle, Washington, Estados Unidos, 98104
        • Univ of Washington
  • Puerto Rico
      • San Juan, Puerto Rico, 009365067
        • Univ of Puerto Rico

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

13 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Have been taking anti-HIV therapy that includes at least 3 anti-HIV drugs and is an acceptable anti-HIV drug combination for 60 to 104 days before study treatment. Patients must not have changed any of the drugs in the 28 days before study entry. (This study has been changed by extending the number of days that anti-HIV therapy has been received.)
  • Have a viral load greater than 500 but less than or equal to 10,000 copies/ml and have had a significant decrease in viral load between 49 and 84 days after starting this anti-HIV therapy. (This study has been changed by extending the length of time of viral load decrease.)
  • Are at least 13 years old (consent of parent or guardian required if under 18).
  • Agree to practice abstinence or use barrier method of birth control (such as condoms) during the study and for 3 months after.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have ever taken ABC.
  • Have received anti-HIV therapy for more than 104 days in the past. (This study has been changed by extending the number of days that anti-HIV therapy has been received.)
  • Have a fever for 7 days in the 30 days before study entry.
  • Have cancer, including Kaposi's sarcoma, that requires chemotherapy.
  • Have an active infection that requires treatment in the 21 days before study entry.
  • Have any opportunistic (AIDS-related) infection or disease that requires a change in medication in the 14 days before study entry.
  • Have any medical condition or history of an illness that the doctor feels would place them at risk or make them unable to complete the study.
  • Are taking drugs that affect the immune system or any experimental anti-HIV drugs, except for their current drug combination.
  • Are taking St. John's wort. (This study has been changed. Previously, patients taking St. John's wort were eligible.)
  • Have received a vaccine in the 21 days before study entry.
  • Are pregnant or breast-feeding.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Enmascaramiento: Doble

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

National Institute of Allergy and Infectious Diseases (NIAID)

Investigadores

  • Silla de estudio: Pablo Tebas
  • Silla de estudio: John Bartlett

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de noviembre de 1999

Finalización del estudio

1 de abril de 2001

Fechas de registro del estudio

Enviado por primera vez

17 de enero de 2000

Primero enviado que cumplió con los criterios de control de calidad

30 de agosto de 2001

Publicado por primera vez (Estimar)

31 de agosto de 2001

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

9 de septiembre de 2008

Última actualización enviada que cumplió con los criterios de control de calidad

8 de septiembre de 2008

Última verificación

1 de junio de 2003

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ACTG A5064
  • AACTG A5064

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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