The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants

Completed · Phase 3

Conditions studied: HIV Infections, Pregnancy

In brief

To determine whether the rate of HIV transmission from mother to infant can be reduced by continuous oral zidovudine (AZT) treatment to HIV infected pregnant women, intravenous AZT during childbirth, and oral AZT treatment of the newborn infant from birth to six weeks of age. The study is also designed to evaluate the safety of AZT for both the pregnant woman and the newborn infant. No method exists to prevent transmission of HIV from an infected mother to her newborn infant. Giving an antiviral agent (such as AZT) to the mother and to the newborn could in theory decrease the risk of infection to the newborn by reducing the exposure of the fetus to maternal virus, or by preventive treatment of the fetus before exposure.

Key facts

Study ID

NCT00000960

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

1496

Expected to finish

1994-06-01

Last updated by the study team

2021-10-29

Who can join

Age: 0 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed for infants:
• Treatment for signs of drug withdrawal (e.g., phenobarbital, chlorpromazine, tincture of opium, paregoric, or Valium).
• Treatment for nonserious conditions (e.g., syphilis treatment, hepatitis B vaccine).
• All essential supportive treatment for conditions that are nonlife threatening as deemed by the on-site pediatrician.
• Acetaminophen.
• Standard immunizations.
• Allowed for women:
• All medications/treatments as required for normal OB care of HIV+ women, except as noted under exclusions.
• Pneumocystis prophylaxis as indicated.
• Topical steroids. Parenteral and oral steroids for 6 or fewer days.
• Concurrent Treatment:
• Allowed for pregnant woman:
• Blood transfusion for anemia (hemoglobin less than 7 g/dl).
• Allowed for infant:
• Blood transfusions for anemia except if attributed to study drug.
• Patients must:
• Have HIV infection.
• Intend to carry pregnancy to term.
• Be willing to be followed by a participating ACTG center for duration of the study.
• Be able to provide informed consent (if available, father of the fetus must also provide informed consent).
• Infants may enroll simultaneously in other pediatric protocols after completing the initial 6 weeks of study treatment.
• Inclusion age for women is 13 years old or more or IRB local age of consent.
• Inclusion age for infants is 0 to 20 months.

You may not qualify if…

• Co-existing Condition:
• Infants with the following conditions or symptoms are excluded:
• Requiring treatment for hyperbilirubinemia (except phototherapy).
• Concurrent Medication:
• Excluded:
• Infants:
• Antiretroviral drugs or vaccines.
• Excluded during current pregnancy:
• Zidovudine (AZT).
• Other antiretroviral agents (e.g., rCD4, CD4-IgG, d4T, didanosine (ddI), dideoxycytidine (ddC)), passive immunotherapy (e.g., HIVIG), anti-HIV vaccines, cytolytic chemotherapeutic agents.
• Corticosteroids for equal to or more than 7 days.
• Patients with the following are excluded:
• Evidence of preexisting fetal anomalies that may (1) result in a high probability that the fetus/infant will not survive to the end of the study period (e.g., anencephaly, renal agenesis, or Potter's syndrome); or (2) increase the fetal tissue concentration of zidovudine (AZT) or its metabolites to a toxic level (e.g., neural tube or ventral wall defects).
• Baseline sonogram completed within 28 days prior to randomization that demonstrates 2nd trimester findings of anencephaly or oligohydramnios, or 3rd trimester findings of unexplained polyhydramnios, fetal hydrops, ascites or other evidence of preexisting in-utero anemia.
• History of intolerance to AZT dose of 500 or less mg/day prior to this pregnancy that resulted in discontinuation of treatment for more than 4 weeks.
• Recipient of AZT during current pregnancy for any indication or meet criteria for AZT as defined by this protocol (CD4+ cell counts less than 200 cells/mm3 or AIDS).
• Infants not having parent/guardian available to give informed consent if necessary.
• Prior Treatment:
• Excluded during current pregnancy:
• Radiation therapy.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• UCSD Med Ctr / Pediatrics / Clinical Sciences — La Jolla, 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
• San Francisco Gen Hosp — San Francisco, California, United States
• Children's Hosp of Denver — Denver, Colorado, United States
• Univ of Connecticut / Farmington — Farmington, Connecticut, United States
• Univ of Connecticut Health Ctr — Farmington, Connecticut, United States
• Howard Univ Hosp — Washington D.C., District of Columbia, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Cook County Hosp — Chicago, Illinois, United States
• Univ of Illinois College of Medicine / Pediatrics — Chicago, Illinois, United States
• Chicago Children's Memorial Hosp — Chicago, Illinois, 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 of Maryland at Baltimore / Univ Med Ctr — Baltimore, Maryland, United States
• Johns Hopkins Hosp - Pediatric — Baltimore, Maryland, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Children's Hosp of Boston — Boston, Massachusetts, United States
• Boston City Hosp / Pediatrics — Boston, Massachusetts, United States
• Beth Israel Deaconess Med Ctr — Boston, Massachusetts, United States
• Baystate Med Ctr of Springfield — Springfield, Massachusetts, United States
• Univ of Alabama at Birmingham Schl of Med / Pediatrics — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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