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Ensayos clínicos

Ensayos clínicos

Outcomes of Anti-HIV Therapy During Early HIV Infection

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00001093, AIEDRP AI-05-005
  • Concluido

Propósito del estudio

To evaluate the effect of potent antiretroviral therapy, initiated before or after HIV seroconversion, on the development and decay rate of the reservoir of latently infected cells and on the development and maintenance of the HIV-specific cellular immune response. To compare the viral burden in transmitting source partners of newly HIV-infected patients and non-transmitting HIV-infected partners of persons with suspected primary HIV infection.

Afección:
Infecciones por el VIH

Detalles del estudio

Although many researchers have recommended initiation of aggressive antiretroviral therapy as soon as possible after HIV infection occurs, the tolerability and efficacy of this approach has not been systemically evaluated. Many features of primary HIV pathogenesis are incompletely understood. A more complete understanding of immune dynamics and viral pathogenesis during primary HIV infection is critical to determine optimal treatment intervention strategies. This study will evaluate the outcomes of potent antiretroviral therapy initiated at different stages of primary HIV infection.Thirty-six of the study patients are coenrolled to ACTG 371 or another treatment protocol. All study drug treatment and toxicity management is performed according to guidelines in these treatment protocols. An untreated cohort of 12 patients is also followed on this study. Patients are stratified at enrollment according to their stage of acute or early HIV infection. Patients are evaluated for virologic, immunologic, and clinical parameters for 96 weeks. In addition, novel studies of source partner identification are proposed. An effort is made to determine the most likely source partner(s) for each study patient on the basis of patient recall of possible exposures. A separate study protocol will evaluate the source partner.

Criterios de exclusión

    Patients will not be eligible for this study if they: Are pregnant or breast-feeding.

Centros de estudio/contactos

California

    Cedars Sinai Med Ctr, Los Angeles, California, 90048, United States

    UCSD, San Diego, California, 92103, United States

    San Francisco Gen Hosp / UCSF AIDS Program, San Francisco, California, 94110, United States

Actualizado: 13 de octubre del 2004

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