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Ensayos clínicos

Ensayos clínicos

Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000917, ACTG 385
  • Terminado

Propósito del estudio

To develop a Pediatric AIDS Clinical Trials Group (PACTG) program for collection, transportation, and storage of umbilical cord blood from 5-10 HIV-exposed infants for possible entry into gene therapy protocols. To determine the influence of maternal factors (viral load, CD4 count, co-infections, and cord blood characteristics) on the recovery of surrogate marker stem cells from the umbilical cord blood of HIV-exposed infected and uninfected infants.

Afección:
Infecciones por el VIH
Embarazo

Detalles del estudio

Gene therapy may provide a new therapeutic approach to pediatric AIDS. Putting an HIV-resistant gene into umbilical cord blood stem cells and transplanting the cells back into the patient could lead to the production of cells that resist HIV infection. If a patient's cells could be engineered to be resistant to supporting the growth of HIV-1, the cells may have improved survival in the presence of HIV-1. To date, an umbilical cord blood bank for HIV-positive deliveries has not been established in the United States. This protocol establishes a repository of banked umbilical cord blood as a first step toward the potential application of gene therapy for the treatment of HIV-infected infants.HIV-infected mothers have about 20 ml of blood drawn to test for infectious diseases (e.g., hepatitis). At time of delivery maternal HIV viral load is measured. After delivery, about 60 ml of blood is collected from the umbilical cord; this blood is labeled and transferred to the umbilical cord blood bank for possible use in future gene therapy studies on the infant. At birth, infant HIV status and general health are assessed. If the infant is found to be HIV-infected, the mother may be approached about the infant's participation in a future gene therapy study. If the infant is not HIV-infected, the cord blood is stored for up to four years and is then released to the mother, or, with her consent, to the research community.

Criterios de exclusión

    Your child will not be eligible for this study if he/she: Is not expected to live more than 6 months. Weighs less than 3.3 pounds.

Centros de estudio/contactos

California

    UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla, California, 920930672, United States

    Long Beach Memorial (Pediatric), Long Beach, California, 90801, United States

    UCLA Med Ctr / Pediatric, Los Angeles, California, 900951752, United States

    Harbor - UCLA Med Ctr / UCLA School of Medicine, Los Angeles, California, 905022004, United States

    Los Angeles County - USC Med Ctr, Los Angeles, California, 90033, United States

    Cedars Sinai / UCLA Med Ctr, Los Angeles, California, 900481804, United States

    UCSF / Moffitt Hosp - Pediatric, San Francisco, California, 941430105, United States

    San Francisco Gen Hosp, San Francisco, California, 94110, United States

Actualizado: 13 de octubre del 2004

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