skip navigation

Skip Nav

Ensayos clínicos

Ensayos clínicos

Effects of Maternal Anti-HIV Treatment on Infants Born to HIV Infected Women

Patrocinador(es) del estudio: AIDS Clinical Trials Group
Números de identificación: NCT00100867, ACTG A5190-P1054
  • Concluido

Propósito del estudio

In clinical trials being conducted throughout the world, pregnant HIV infected women are given anti-HIV drugs before, during, and after they give birth to prevent mother-to-child transmission of HIV. However, the effects of this anti-HIV treatment on infants is unknown. The purpose of this study is to determine the safety, toxicity, and potential side effects of maternal anti-HIV treatment on infants born to these HIV infected women. Study hypothesis: Specific combination antiretroviral regimens used in clinical trials in diverse areas of the world are safe and well tolerated during pregnancy and breastfeeding periods, and are not associated with adverse side effects to the fetus, neonate, and/or breastfeeding infant. These regimens are associated with reduction of mother-to-child HIV transmission.

Afección:
Infecciones por el VIH

Detalles del estudio

Many HIV infected women outside the United States enroll in clinical trials that provide them antiretroviral therapy (ART) to prevent mother-to-child transmission of HIV. However, data are limited on the safety, toxicity, and adverse effects that maternal ART may have on infants born to HIV infected women. This study will monitor the adverse effects and potential benefits of maternal ART on these infants.



No antiretrovirals will be given in this study. This study will last 18 months. Infants will be enrolled in the study within 48 hours of birth. There will be 6 study visits starting at study entry and every 6 weeks thereafter. Infants will undergo blood and urine collection, and medical history assessments will occur at every visit. Mothers will also be evaluated at these visits.Many HIV infected women outside the United States enroll in clinical trials that provide them antiretroviral therapy (ART) to prevent mother-to-child transmission of HIV. However, data are limited on the safety, toxicity, and adverse effects that maternal ART may have on infants born to HIV infected women. This study will monitor the adverse effects and potential benefits of maternal ART on these infants.



No antiretrovirals will be given in this study. This study will last 18 months. Infants will be enrolled in the study within 48 hours of birth. There will be 6 study visits starting at study entry and every 6 weeks thereafter. Infants will undergo blood and urine collection, and medical history assessments will occur at every visit. Mothers will also be evaluated at these visits.

Criterios de inclusión

    • Infant born to HIV-1 infected mother enrolled in NIH-sponsored, international antiretroviral treatment trial AND who has had either in utero or postpartum antiretroviral exposure
    • Parent or guardian willing to provide informed consent

Criterios de exclusión

    :
    • Infant with no exposure to antiretrovirals OR who received only intrapartum antiretroviral exposure

Centros de estudio/contactos

Botswana

    The Gaborone BHP Study Clinic, Gaborone, Botswana

    The Molepolole BHP Study Clinic, Gaborone, Botswana

Brazil

    Hospital dos Servidores do Estado, Rio de Janeiro, 22261-161, Brazil

    Hospital Geral de Nova Iguacu, Rio de Janeiro, 22261-161, Brazil

    Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Fundacao Oswaldo Cruz, Rio de Janeiro,, 21045-900, Brazil

India

    YRG Center for AIDS Research and Education, Chennai, 60001-7, India

    NARI AIDS Research Institute, Department of Clinical Science, Pune, 60001-7, India

    NARI AIDS Research Institute, Dr. Kotnis Dispensary, Pune, 60001-7, India

    NARI-NIV Clinic, Pune, 60001-7, India

Malawi

    Univ. of Malawi, John Hopkins Project, Blantyre, 60001-7, Malawi

    University of North Carolina Project (UNC Project), Lilongwe, 60001-7, Malawi

Lima

    Asociacion Civil IMPACTA Salud y Educacion,, Miraflores, Lima, 18, Peru

    Asociacion Civil IMPACTA Salud y Educacion, Lince, Lima, Lima, 18, Peru

    University of the Witwatersrand, Johannesburg, Lima, 18, South Africa

    Perinatal HIV Research Unit at Chris Baragwanath Hospital, Johannesburg, Lima, 18, South Africa

Bankok

    Siriraj Hospital, Bangkok Noi, Bankok, 10700, Thailand

Chonburi

    Chonburi Regional Hospital, Chonburi, Muang, Chonburi, 20000, Thailand

Muang Phayao

    Phayao Provincial Hospital, Phayao, Tambol Mae Sai, Muang Phayao, 56000, Thailand

    Bhumibol Adulyadej Hospital, Bangkok, Bangkok, Muang Phayao, 10120, Thailand

    Chiang Mai University, Chang Mai, Muang Phayao, 10120, Thailand

    Institut de Recherche pour Developpement (IRD), Chiang Mai, Muang Phayao, 50200, Thailand

    Prapokklao Hospital Chantaburi, Muang Chantaburi, Muang Phayao, 22000, Thailand

    University of Zimbabwe, Harare, Muang Phayao, 22000, Zimbabwe

Actualizado: 27 de octubre del 2005

Volver arriba