A Phase III Randomized, Double-Blind, Controlled Study of the Use of Anti-HIV Immune Serum Globulin (HIVIG) for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine (AZT)
HIV Infections, Pregnancy

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Pregnancy, Pregnancy Complications, Infectious, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Immunoglobulins, Intravenous, Immunization, Passive
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Women - Medications as required for obstetrical management of HIV infection (e.g., acyclovir, ketoconazole, isoniazid, antibiotics, or other antiretroviral therapy if intolerant or failing on AZT), unless specifically excluded. Infants - Drug treatment for signs of drug withdrawal (phenobarbital, chlorpromazine, tincture of opium, paregoric or Valium). Infants - Medications as indicated for management of an HIV-exposed infant (e.g., hepatitis B vaccine, syphilis treatment, Pneumocystis carinii pneumonia prophylaxis). Patients must have: Documented HIV infection. Been receiving AZT during current pregnancy for medical indications. Gestational age between 20 and 30 weeks. Intention to carry pregnancy to term. Available venous access (placement of central line or Hickman catheter not indicated for study purposes). Willingness to be followed by a participating site for study duration. NOTE: Father of fetus (if available after a reasonable attempt to contact him) must also provide informed consent. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Illness associated with excessive protein loss, e.g., severe proteinuria (protein >= 4 g protein in a 24-hour urine collection). Patients with the following prior conditions are excluded: Evidence of pre-existing fetal anomalies (e.g., anencephaly, renal agenesis, or Potter's syndrome) that may result in a high probability that the fetus-infant would not survive to the end of the study period. Chorionic villus sampling (CVS) or percutaneous umbilical blood sampling (PUBS) occurring in this pregnancy prior to study entry. Illness associated with excessive protein loss, e.g., chronic diarrhea with no documented weight gain in a 3-month period during pregnancy. Pre-existing conditions such as hypogammaglobulinemia or immune thrombocytopenia that are felt to require IVIG therapy. Prior Medication: Excluded: Receipt of anti-HIV vaccines or passive immunotherapy with HIVIG or IVIG during this pregnancy prior to study entry. Receipt of antiretroviral agents other than AZT during this pregnancy prior to study entry (e.g., rCD4, CD4-IgG, d4T, ddC, ddI).
Sites / Locations
- UCSD Med Ctr / Pediatrics / Clinical Sciences
- Los Angeles County - USC Med Ctr
- UCLA Med Ctr / Pediatric
- Harbor - UCLA Med Ctr / UCLA School of Medicine
- San Francisco Gen Hosp
- UCSF / Moffitt Hosp - Pediatric
- Denver Gen Hosp
- Children's Hosp of Denver
- Univ of Connecticut / Farmington
- Children's Hosp of Washington DC
- Washington Hosp Ctr
- Howard Univ Hosp
- Univ of Florida Health Science Ctr / Pediatrics
- Univ of Miami (Pediatric)
- Univ of Illinois College of Medicine / Pediatrics
- Tulane Univ / Charity Hosp of New Orleans
- Univ Hosp
- Univ of Maryland at Baltimore / Univ Med Ctr
- Johns Hopkins Hosp - Pediatric
- Children's Hosp of Boston
- Brigham and Women's Hosp
- Boston City Hosp / Pediatrics
- Baystate Med Ctr of Springfield
- Univ of Massachusetts Med School
- Children's Hosp of Michigan
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp
- Children's Hosp at Albany Med Ctr
- Bronx Lebanon Hosp Ctr
- Bellevue Hosp / New York Univ Med Ctr
- Mount Sinai Med Ctr / Pediatrics
- Columbia Presbyterian Med Ctr
- State Univ of New York at Stony Brook
- SUNY Health Sciences Ctr at Syracuse / Pediatrics
- Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
- Case Western Reserve Univ - Pediatric
- Children's Hosp of Philadelphia
- Hosp of the Univ of Pennsylvania
- Thomas Jefferson Univ Hosp
- Saint Christopher's Hosp for Children
- Temple Univ School of Medicine
- Med Univ of South Carolina
- Regional Med Ctr at Memphis
- Methodist Hosp Central
- Saint Jude Children's Research Hosp of Memphis
- Children's Med Ctr of Dallas
- Hermann Hosp / Univ Texas Health Science Ctr
- Texas Children's Hosp / Baylor Univ
- Children's Hospital & Medical Center / Seattle ACTU
- Ramon Ruiz Arnau Univ Hosp / Pediatrics
- Univ of Puerto Rico / Univ Children's Hosp AIDS
- San Juan City Hosp