The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants
- Conditions
- HIV InfectionsPregnancy
- Registration Number
- NCT00000960
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1496
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (62)
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
🇵🇷San Juan, Puerto Rico
Univ of Massachusetts Med Ctr
🇺🇸Worcester, Massachusetts, United States
Thomas Jefferson Univ Hosp
🇺🇸Philadelphia, Pennsylvania, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
🇺🇸Syracuse, New York, United States
UPR Children's Hosp / UPR School of Medicine
🇵🇷San Juan, Puerto Rico
San Juan City Hosp
🇵🇷San Juan, Puerto Rico
Univ of Connecticut / Farmington
🇺🇸Farmington, Connecticut, United States
Univ of Connecticut Health Ctr
🇺🇸Farmington, Connecticut, United States
Univ of Illinois College of Medicine / Pediatrics
🇺🇸Chicago, Illinois, United States
Univ of Chicago Children's Hosp
🇺🇸Chicago, Illinois, 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
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Univ of Miami (Pediatric)
🇺🇸Miami, Florida, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Children's Hosp of Denver
🇺🇸Denver, Colorado, United States
Univ of Alabama at Birmingham Schl of Med / Pediatrics
🇺🇸Birmingham, Alabama, United States
Children's Hosp of Michigan
🇺🇸Detroit, Michigan, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Cook County Hosp
🇺🇸Chicago, Illinois, 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 at Albany Med Ctr
🇺🇸Albany, New York, United States
SUNY - Brooklyn
🇺🇸Brooklyn, New York, United States
SUNY / Health Sciences Ctr at Brooklyn / Pediatrics
🇺🇸Brooklyn, New York, United States
Cornell Univ Med College
🇺🇸New York, New York, United States
Beth Israel Med Ctr / Pediatrics
🇺🇸New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Mount Sinai Med Ctr / Pediatrics
🇺🇸New York, New York, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
State Univ of New York at Stony Brook
🇺🇸Stony Brook, New York, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Westchester Hosp
🇺🇸Valhalla, New York, United States
Rhode Island Hosp / Brown Univ
🇺🇸Providence, Rhode Island, United States
Saint Jude Children's Research Hosp of Memphis
🇺🇸Memphis, Tennessee, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
🇵🇷Bayamon, Puerto Rico
UCSD Med Ctr / Pediatrics / Clinical Sciences
🇺🇸La Jolla, California, United States
Chicago Children's Memorial Hosp
🇺🇸Chicago, Illinois, United States
Tulane Univ / Charity Hosp of New Orleans
🇺🇸New Orleans, Louisiana, United States
UCLA Med Ctr / Pediatric
🇺🇸Los Angeles, California, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
🇺🇸Los Angeles, California, United States
Howard Univ Hosp
🇺🇸Washington, District of Columbia, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Beth Israel Deaconess Med Ctr
🇺🇸Boston, Massachusetts, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
UMDNJ - New Jersy Med School
🇺🇸Newark, New Jersey, United States
Baystate Med Ctr of Springfield
🇺🇸Springfield, Massachusetts, United States
Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
Hosp of the Univ of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Children's Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
🇺🇸Newark, New Jersey, United States
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
🇺🇸Newark, New Jersey, United States
Carolinas Med Ctr
🇺🇸Charlotte, North Carolina, United States
Children's Hosp of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hosp of Seattle
🇺🇸Seattle, Washington, United States
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States
Lyndon Baines Johnson Gen Hosp
🇺🇸Houston, Texas, United States
Texas Children's Hosp / Baylor Univ
🇺🇸Houston, Texas, United States