Completed

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

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What is being tested

Zidovudine

Drug
Who is being recruted

HIV Infections

+ Pregnancy
Until 60 Years
How is the trial designed

Treatment Study

Phase 3
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 29, 2021
Sourced from a government-validated database.Claim as a partner

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. 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. Patients are enrolled during their pregnancy, between 14 and 34 weeks of gestation. They are chosen by random selection to receive AZT or placebo. Treatment continues until labor at which time they begin to receive continuous intravenous study drug. Study drug treatment is discontinued after the umbilical cord is clamped. AZT is then offered all women as per labeled indications for 6 weeks postpartum, while appropriate medical followup is being arranged. Mothers who develop an AIDS defining illness or whose CD4+ cell counts decrease to less than 200 cells/mm3 during pregnancy are offered open-label drug at that time. The mother is followed by her primary obstetrician at an AIDS Clinical Trials Unit (ACTU) or subunit facility. The mother may deliver at the ACTU or a non-ACTU site. Treatment of the infant is started in the newborn nursery and continues on an outpatient basis. Infants receive the same study treatment as the mother for 6 weeks, and are monitored to week 78.

Official TitleA Phase III Randomized Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Tolerance of Oral Zidovudine (AZT) in Pregnant HIV Infected Women and Their Infants 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 29, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
1496 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Until 60 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Pregnancy
Criteria

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 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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 62 locations
Suspended
Univ of Alabama at Birmingham Schl of Med / PediatricsBirmingham, United StatesSee the location
Suspended
Univ of Alabama at BirminghamBirmingham, United States
Suspended
UCSD Med Ctr / Pediatrics / Clinical SciencesLa Jolla, United States
Suspended
Los Angeles County - USC Med CtrLos Angeles, United States

Completed62 Study Centers