A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women.
The Safety, Tolerance, and Pharmacokinetics of Zidovudine in Premature Infants Exposed to HIV.
2 other identifiers
interventional
35
2 countries
36
Brief Summary
The purpose of this study is to examine the safety and tolerability of ZDV when given to premature infants born to HIV-positive women to prevent HIV infection. ZDV has been used successfully to prevent the transmission of HIV from mother to child during pregnancy and birth. However, ZDV has been given to very few premature babies, and the best dose to use has not yet been determined.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv-infections
36 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
First Submitted
Initial submission to the registry
November 2, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 28, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Your baby may be eligible for this study if he/she:
- Requires ZDV (as decided by your doctor) because you are HIV-positive.
- Is 1-5 days old and was born prematurely.
You may not qualify if:
- Your baby will not be eligible for this study if he/she:
- Is not expected to live 6 weeks because of severe illness.
- Is having problems with blood pressure or is not urinating enough.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233, United States
Phoenix Childrens Hosp
Phoenix, Arizona, 85006, 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
Children's Hosp of Oakland
Oakland, California, 946091809, United States
San Francisco Gen Hosp
San Francisco, California, 94110, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105, United States
Univ of Florida Gainesville
Gainesville, Florida, 32610, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209, United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136, United States
Univ of Miami (Pediatric)
Miami, Florida, 33161, United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306, United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612, United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202, United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724, United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118, United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001, United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714, United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208, United States
Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
Harlem Hosp Ctr
New York, New York, 10037, United States
Univ of Rochester Med Ctr
Rochester, New York, 146420001, 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
Westchester Hosp
Valhalla, New York, 10595, United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499, United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312, United States
Children's Med Ctr of Dallas
Dallas, Texas, 75235, United States
Children's Hosp of the King's Daughters
Norfolk, Virginia, 23507, United States
Med College of Virginia
Richmond, Virginia, 23219, United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, 009365067, Puerto Rico
Related Publications (1)
Capparelli EV, Mirochnick M, Dankner WM, Blanchard S, Mofenson L, McSherry GD, Gay H, Ciupak G, Smith B, Connor JD; Pediatric AIDS Clinical Trials Group 331 Investigators. Pharmacokinetics and tolerance of zidovudine in preterm infants. J Pediatr. 2003 Jan;142(1):47-52. doi: 10.1067/mpd.2003.mpd0335.
PMID: 12520254BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mirochnick M
- STUDY CHAIR
Dankner D
- STUDY CHAIR
Capparelli E
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
February 1, 2000
Last Updated
October 28, 2021
Record last verified: 2021-10