Completed

Assessment of AZT-Resistant HIV Transmission in Pregnant Women

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Who is being recruted

Blood-Borne Infections+17

+ Urogenital Diseases

+ Genital Diseases

From 13 to 60 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Observational
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00000828
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

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.
Conditions
Criteria

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

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsPregnancy ComplicationsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexPregnancy Complications, InfectiousHIV Infections

Criteria

4 inclusion criteria required to participate
At least 6 months of prior AZT therapy, including continuous AZT therapy during the current pregnancy
CD4 count <= 300 cells/mm3
Gestational age of 20-36 weeks, with intention to carry pregnancy to term
HIV seropositivity
2 exclusion criteria prevent from participating
Antiretrovirals other than AZT
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

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

Univ of Alabama at Birmingham Schl of Med / Pediatrics

Birmingham, United StatesOpen Univ of Alabama at Birmingham Schl of Med / Pediatrics in Google Maps

UCSD Med Ctr / Pediatrics / Clinical Sciences

La Jolla, United States

Long Beach Memorial (Pediatric)

Long Beach, United States

Los Angeles County - USC Med Ctr

Los Angeles, United States
Completed29 Study Centers