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Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine

Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00000828
Enrollment
250
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Pregnancy

Keywords

Pregnancy, Pregnancy Complications, Infectious, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Drug Resistance, Microbial, Disease Transmission, Vertical

Brief summary

To identify patterns of zidovudine ( AZT ) susceptibility among mother/infant pairs with perinatal HIV transmission. 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.

Detailed description

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.

Interventions

None listed

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
Lead SponsorNIH

Eligibility

Sex/Gender
FEMALE
Age
13 Years to 60 Years
Healthy volunteers
No

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.

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026