Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine
Data Collection
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.250 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 13 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 29 locations
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