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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000828
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: October 1997
  Purpose

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.


Condition
HIV Infections
Pregnancy

Study Type: Observational
Official Title: Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 250
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.

  Eligibility

Ages Eligible for Study:   13 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000828

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

Publications:
Bardeguez AD, Taylor U, Appuzio J, Leus C, Lister M, Denny T, Palumbo P, Connor E. Characteristics of pregnant women infected with human immunodeficiency virus 1: Newark perinatal transmission study. Int Conf AIDS. 1991 Jun 16-21;7(2):193 (abstract no WB2044)
Japour AJ, Welles S, McIntosh K, Colson A, Chung P, Lockman S, Davenny K, Fowler MG, Hansen IC, Kalish L, Moye J, Rick K, Zorilla C, Pitt J. ZDV resistance (ZDVR) mutations in ZDV exposed mother infant pairs: preliminary findings from the women and infants transmission study (WITS). Int Conf AIDS. 1996 Jul 7-12;11(1):370 (abstract no TuC2606)

ClinicalTrials.gov Identifier: NCT00000828     History of Changes
Other Study ID Numbers: ACTG 255
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Pregnancy
Pregnancy Complications, Infectious
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Drug Resistance, Microbial
Disease Transmission, Vertical

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 23, 2014