The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants
A 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
2 other identifiers
interventional
1,496
2 countries
62
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hiv-infections
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
June 1, 1994
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 29, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
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:
- 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.
- +6 more criteria
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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, 35294, United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004, United States
San Francisco Gen Hosp
San Francisco, California, 94110, United States
Children's Hosp of Denver
Denver, Colorado, 802181088, United States
Univ of Connecticut / Farmington
Farmington, Connecticut, 06032, United States
Univ of Connecticut Health Ctr
Farmington, Connecticut, 06032, United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060, United States
Univ of Miami (Pediatric)
Miami, Florida, 33161, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394, United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470, United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699, United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201, United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724, United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199, United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655, United States
Children's Hosp of Michigan
Detroit, Michigan, 48201, United States
UMDNJ - New Jersy Med School
Newark, New Jersey, 071032714, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714, United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198, United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208, United States
SUNY - Brooklyn
Brooklyn, New York, 11203, United States
SUNY / Health Sciences Ctr at Brooklyn / Pediatrics
Brooklyn, New York, 11203, United States
Beth Israel Med Ctr / Pediatrics
New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Cornell Univ Med College
New York, New York, 10021, United States
Mount Sinai Med Ctr / Pediatrics
New York, New York, 10029, United States
Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10457, United States
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Westchester Hosp
Valhalla, New York, 10595, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203, United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318, United States
Hosp of the Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098, United States
Rhode Island Hosp / Brown Univ
Providence, Rhode Island, 02903, United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312, United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794, United States
Children's Med Ctr of Dallas
Dallas, Texas, 75235, United States
Lyndon Baines Johnson Gen Hosp
Houston, Texas, 77030, United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030, United States
Children's Hosp of Seattle
Seattle, Washington, 98105, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, 00956, Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, 009365067, Puerto Rico
UPR Children's Hosp / UPR School of Medicine
San Juan, 009365067, Puerto Rico
San Juan City Hosp
San Juan, 009367344, Puerto Rico
Related Publications (11)
Sperling RS, Shapiro DE, Coombs RW, Todd JA, Herman SA, McSherry GD, O'Sullivan MJ, Van Dyke RB, Jimenez E, Rouzioux C, Flynn PM, Sullivan JL. Maternal viral load, zidovudine treatment, and the risk of transmission of human immunodeficiency virus type 1 from mother to infant. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1996 Nov 28;335(22):1621-9. doi: 10.1056/NEJM199611283352201.
PMID: 8965861BACKGROUNDConnor EM, Sperling RS, Gelber R, Kiselev P, Scott G, O'Sullivan MJ, VanDyke R, Bey M, Shearer W, Jacobson RL, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1994 Nov 3;331(18):1173-80. doi: 10.1056/NEJM199411033311801.
PMID: 7935654BACKGROUNDSperling RS, Shapiro DE, McSherry GD, Britto P, Cunningham BE, Culnane M, Coombs RW, Scott G, Van Dyke RB, Shearer WT, Jimenez E, Diaz C, Harrison DD, Delfraissy JF. Safety of the maternal-infant zidovudine regimen utilized in the Pediatric AIDS Clinical Trial Group 076 Study. AIDS. 1998 Oct 1;12(14):1805-13. doi: 10.1097/00002030-199814000-00012.
PMID: 9792381BACKGROUNDWiznia AA, Crane M, Lambert G, Sansary J, Harris A, Solomon L. Zidovudine use to reduce perinatal HIV type 1 transmission in an urban medical center. JAMA. 1996 May 15;275(19):1504-6.
PMID: 8622226BACKGROUNDRouzioux C. Prevention of maternal HIV transmission. Practical guidelines. Drugs. 1995;49 Suppl 1:17-24; discussion 38-40. doi: 10.2165/00003495-199500491-00006.
PMID: 7614898BACKGROUNDDickover RE, Garratty EM, Herman SA, Sim MS, Plaeger S, Boyer PJ, Keller M, Deveikis A, Stiehm ER, Bryson YJ. Identification of levels of maternal HIV-1 RNA associated with risk of perinatal transmission. Effect of maternal zidovudine treatment on viral load. JAMA. 1996 Feb 28;275(8):599-605.
PMID: 8594240BACKGROUNDCulnane M, Fowler M, Lee SS, McSherry G, Brady M, O'Donnell K, Mofenson L, Gortmaker SL, Shapiro DE, Scott G, Jimenez E, Moore EC, Diaz C, Flynn PM, Cunningham B, Oleske J. Lack of long-term effects of in utero exposure to zidovudine among uninfected children born to HIV-infected women. Pediatric AIDS Clinical Trials Group Protocol 219/076 Teams. JAMA. 1999 Jan 13;281(2):151-7. doi: 10.1001/jama.281.2.151.
PMID: 9917118BACKGROUNDShearer WT, Quinn TC, LaRussa P, Lew JF, Mofenson L, Almy S, Rich K, Handelsman E, Diaz C, Pagano M, Smeriglio V, Kalish LA. Viral load and disease progression in infants infected with human immunodeficiency virus type 1. Women and Infants Transmission Study Group. N Engl J Med. 1997 May 8;336(19):1337-42. doi: 10.1056/NEJM199705083361901.
PMID: 9134873BACKGROUNDFrenkel LM, Cowles MK, Shapiro DE, Melvin AJ, Watts DH, McLellan C, Mohan K, Murante B, Burchett S, Bryson YJ, O'Sullivan MJ, Mitchell C, Landers D. Analysis of the maternal components of the AIDS clinical trial group 076 zidovudine regimen in the prevention of mother-to-infant transmission of human immunodeficiency virus type 1. J Infect Dis. 1997 Apr;175(4):971-4. doi: 10.1086/514003.
PMID: 9086162BACKGROUNDNewell ML, Gray G, Bryson YJ. Prevention of mother-to-child transmission of HIV-1 infection. AIDS. 1997;11 Suppl A:S165-72. No abstract available.
PMID: 9451981BACKGROUNDEdathodu J, Halim MM, Dahham MB, Alrajhi AA. Mother-to-child transmission of HIV: experience at a referral hospital in Saudi Arabia. Ann Saudi Med. 2010 Jan-Feb;30(1):15-7. doi: 10.4103/0256-4947.59367.
PMID: 20103953RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
E Connor
- STUDY CHAIR
R Sperling