CompletedPhase 3

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

United States, Puerto Rico1,496 participants

Plain-language summary

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.

Who can participate

Age range

1 Day – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria 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. Exclusion Criteria Co-existing Condition: Infants with the following conditions or symptoms…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00000960

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

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