Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Pregnancy
Phase: N/A
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Bardeguez AD, Study Chair
Pitt J, Study Chair
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.
Clinical Details
Official title: Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine
Study design: Natural History
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
Minimum age: 13 Years.
Maximum age: 60 Years.
Gender(s): Female.
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.
Locations and Contacts
San Juan City Hosp, San Juan 009367344, Puerto Rico
Univ of Alabama at Birmingham Schl of Med / Pediatrics, Birmingham, Alabama 35294, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla, California 920930672, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine, Los Angeles, California 905022004, United States
UCLA Med Ctr / Pediatric, Los Angeles, California 900951752, United States
Long Beach Memorial (Pediatric), Long Beach, California 90801, United States
Los Angeles County - USC Med Ctr, Los Angeles, California 90033, United States
Univ of Connecticut / Farmington, Farmington, Connecticut 06032, United States
Connecticut Children's Med Ctr - Pediatric, Hartford, Connecticut 06106, United States
Howard Univ Hosp, Washington, District of Columbia 20060, United States
Children's Hosp of Washington DC, Washington, District of Columbia 200102916, United States
Univ of Miami (Pediatric), Miami, Florida 33161, United States
Univ of Chicago Children's Hosp, Chicago, Illinois 606371470, United States
Tulane Univ / Charity Hosp of New Orleans, New Orleans, Louisiana 701122699, United States
Univ Hosp, New Orleans, Louisiana 70112, United States
Johns Hopkins Hosp - Pediatric, Baltimore, Maryland 212874933, United States
Children's Hosp of Boston, Boston, Massachusetts 021155724, United States
Brigham and Women's Hosp, Boston, Massachusetts 02115, United States
Baystate Med Ctr of Springfield, Springfield, Massachusetts 01199, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark, New Jersey 071032714, United States
Univ of Rochester Medical Center, Rochester, New York 14642, United States
Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States
Columbia Presbyterian Med Ctr, New York, New York 10032, United States
Mount Sinai Med Ctr / Pediatrics, New York, New York 10029, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics, Syracuse, New York 13210, United States
Bronx Lebanon Hosp Ctr, Bronx, New York 10457, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr, New York, New York 10032, United States
Duke Univ Med Ctr, Durham, North Carolina 277103499, United States
Columbus Children's Hosp, Columbus, Ohio 432052696, United States
Additional Information
Related publications: Bardeguez AD. Management of HIV infection for the childbearing age woman. Clin Obstet Gynecol. 1996 Jun;39(2):344-60. Review. No abstract available. 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) Garcia PM, Kalish LA, Pitt J, Minkoff H, Quinn TC, Burchett SK, Kornegay J, Jackson B, Moye J, Hanson C, Zorrilla C, Lew JF. Maternal levels of plasma human immunodeficiency virus type 1 RNA and the risk of perinatal transmission. Women and Infants Transmission Study Group. N Engl J Med. 1999 Aug 5;341(6):394-402.
Last updated: June 23, 2005
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