Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine
Collecte de données
Infections transmises par le sang+11
+ Maladies génito-urinaires
+ Maladies Génitales
Résumé
Most HIV-infected infants acquire their disease via perinatal transmission. Since transmission of HIV-resistant strains to infants could alter the course of disease and response to currently recommended treatment, a study to assess the patterns of AZT susceptibility among mother/infant pairs with perinatal transmission is essential to delineate future therapeutic strategies. HIV-infected pregnant women are enrolled at 20-36 weeks gestation. Patients have blood drawn for HIV culture at study entry and at delivery. Infants have blood drawn for HIV culture at delivery and at 1, 3, 6, and 18 months of age.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.250 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.De 13 à 60 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria Prior Medication: Required: * At least 6 months of prior AZT, including continuously during the current pregnancy. Patients must have: * HIV seropositivity. * CD4 count \<= 300 cells/mm3. * Gestational age of 20-36 weeks, with intention to carry pregnancy to term. * At least 6 months of prior AZT therapy, including continuous AZT therapy during the current pregnancy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Evidence of pre-existing fetal anomalies that would preclude survival to the end of the study, such as anencephaly, renal agenesis, or Potter's syndrome. Concurrent Medication: Excluded: * Antiretrovirals other than AZT.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 29 sites
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, United StatesLong Beach Memorial (Pediatric)
Long Beach, United StatesLos Angeles County - USC Med Ctr
Los Angeles, United States