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

Completed

Conditions studied: HIV Infections, Pregnancy

In brief

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.

Key facts

Study ID

NCT00000828

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

250

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Alabama at Birmingham Schl of Med / Pediatrics — Birmingham, Alabama, United States
• UCSD Med Ctr / Pediatrics / Clinical Sciences — La Jolla, California, United States
• Long Beach Memorial (Pediatric) — Long Beach, California, United States
• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• UCLA Med Ctr / Pediatric — Los Angeles, California, United States
• Harbor - UCLA Med Ctr / UCLA School of Medicine — Los Angeles, California, United States
• Univ of Connecticut / Farmington — Farmington, Connecticut, United States
• Connecticut Children's Med Ctr - Pediatric — Hartford, Connecticut, United States
• Children's Hosp of Washington DC — Washington D.C., District of Columbia, United States
• Howard Univ Hosp — Washington D.C., District of Columbia, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• Univ of Chicago Children's Hosp — Chicago, Illinois, United States
• Tulane Univ / Charity Hosp of New Orleans — New Orleans, Louisiana, United States
• Univ Hosp — New Orleans, Louisiana, United States
• Johns Hopkins Hosp - Pediatric — Baltimore, Maryland, United States
• Children's Hosp of Boston — Boston, Massachusetts, United States
• Brigham and Women's Hosp — Boston, Massachusetts, United States
• Baystate Med Ctr of Springfield — Springfield, Massachusetts, United States
• Univ of Medicine & Dentistry of New Jersey / Univ Hosp — Newark, New Jersey, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Mount Sinai Med Ctr / Pediatrics — New York, New York, United States
• Columbia Presbyterian Med Ctr — New York, New York, United States
• Incarnation Children's Ctr / Columbia Presbyterian Med Ctr — New York, New York, United States
• Univ of Rochester Medical Center — Rochester, New York, United States
• SUNY Health Sciences Ctr at Syracuse / Pediatrics — Syracuse, New York, United States

Full record on ClinicalTrials.gov

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