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)

Completed · Phase 3

Conditions studied: HIV Infections, Pregnancy

In brief

To evaluate the effect of anti-HIV immune serum globulin (HIVIG) versus immune globulin (IVIG) administered during pregnancy and to the newborn, in combination with zidovudine (AZT) administered intrapartum and to the newborn, on incidence of HIV infection in infants born to HIV-infected women who received AZT during pregnancy for medical indications. Vertical transmission of HIV from mother to child may occur before, during, or after parturition (via breast-feeding). It is believed that therapy administered both during pregnancy and intrapartum may help prevent vertical transmission. Additionally, adjunctive short-term antiretroviral therapy for the newborn, following the intensive viral exposure presumed to occur at birth, may be necessary.

Key facts

Study ID

NCT00000751

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

1600

Expected to finish

2007-08-01

Last updated by the study team

2008-09-30

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• 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
• San Francisco Gen Hosp — San Francisco, California, United States
• UCSF / Moffitt Hosp - Pediatric — San Francisco, California, United States
• Denver Gen Hosp — Denver, Colorado, United States
• Children's Hosp of Denver — Denver, Colorado, United States
• Univ of Connecticut / Farmington — Farmington, Connecticut, United States
• Children's Hosp of Washington DC — Washington D.C., District of Columbia, United States
• Washington Hosp Ctr — Washington D.C., District of Columbia, United States
• Howard Univ Hosp — Washington D.C., District of Columbia, United States
• Univ of Florida Health Science Ctr / Pediatrics — Jacksonville, Florida, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• Univ of Illinois College of Medicine / Pediatrics — Chicago, Illinois, United States
• Tulane Univ / Charity Hosp of New Orleans — New Orleans, Louisiana, United States
• Univ Hosp — New Orleans, Louisiana, United States
• Univ of Maryland at Baltimore / Univ Med Ctr — Baltimore, Maryland, 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
• Boston City Hosp / Pediatrics — Boston, Massachusetts, United States
• Baystate Med Ctr of Springfield — Springfield, Massachusetts, United States
• Univ of Massachusetts Med School — Worcester, Massachusetts, United States
• Children's Hosp of Michigan — Detroit, Michigan, United States
• UCSD Med Ctr / Pediatrics / Clinical Sciences — La Jolla, California, United States

Full record on ClinicalTrials.gov

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