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

June 23, 2005 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 009367344
        • San Juan City Hosp
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Univ of Alabama at Birmingham Schl of Med / Pediatrics
    • California
      • La Jolla, California, United States, 920930672
        • UCSD Med Ctr / Pediatrics / Clinical Sciences
      • Long Beach, California, United States, 90801
        • Long Beach Memorial (Pediatric)
      • Los Angeles, California, United States, 90033
        • Los Angeles County - USC Med Ctr
      • Los Angeles, California, United States, 905022004
        • Harbor - UCLA Med Ctr / UCLA School of Medicine
      • Los Angeles, California, United States, 900951752
        • UCLA Med Ctr / Pediatric
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Univ of Connecticut / Farmington
      • Hartford, Connecticut, United States, 06106
        • Connecticut Children's Med Ctr - Pediatric
    • District of Columbia
      • Washington, District of Columbia, United States, 200102916
        • Children's Hosp of Washington DC
      • Washington, District of Columbia, United States, 20060
        • Howard Univ Hosp
    • Florida
      • Miami, Florida, United States, 33161
        • Univ of Miami (Pediatric)
    • Illinois
      • Chicago, Illinois, United States, 606371470
        • Univ of Chicago Children's Hosp
    • Louisiana
      • New Orleans, Louisiana, United States, 701122699
        • Tulane Univ / Charity Hosp of New Orleans
      • New Orleans, Louisiana, United States, 70112
        • Univ Hosp
    • Maryland
      • Baltimore, Maryland, United States, 212874933
        • Johns Hopkins Hosp - Pediatric
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hosp
      • Boston, Massachusetts, United States, 021155724
        • Children's Hosp of Boston
      • Springfield, Massachusetts, United States, 01199
        • Baystate Med Ctr of Springfield
    • New Jersey
      • Newark, New Jersey, United States, 071032714
        • Univ of Medicine & Dentistry of New Jersey / Univ Hosp
    • New York
      • Bronx, New York, United States, 10457
        • Bronx Lebanon Hosp Ctr
      • New York, New York, United States, 10016
        • Bellevue Hosp / New York Univ Med Ctr
      • New York, New York, United States, 10032
        • Columbia Presbyterian Med Ctr
      • New York, New York, United States, 10032
        • Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr / Pediatrics
      • Rochester, New York, United States, 14642
        • Univ of Rochester Medical Center
      • Syracuse, New York, United States, 13210
        • SUNY Health Sciences Ctr at Syracuse / Pediatrics
    • North Carolina
      • Durham, North Carolina, United States, 277103499
        • Duke Univ Med Ctr
    • Ohio
      • Columbus, Ohio, United States, 432052696
        • Columbus Children's Hosp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

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

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Bardeguez AD
  • Study Chair: Pitt J

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

October 1, 1997

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 255

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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