A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women.
NCT ID: NCT00000855
Last Updated: 2021-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2000-02-29
Brief Summary
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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.
Detailed Description
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Premature infants less than or equal to 34 weeks gestational age at birth and begun on ZDV by their clinical caregivers will be entered into the protocol within the first 5 days of life. Upon entry, ZDV will be administered every 12 hours intravenously or orally. The study will require 9 serum samples for ZDV assay collected over 30 days, some additional clinical laboratory tests collected over 12 weeks, collection of 3 spot urine samples, and collection of routine clinical data.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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Zidovudine
Eligibility Criteria
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Inclusion Criteria
* Requires ZDV (as decided by your doctor) because you are HIV-positive.
* Is 1-5 days old and was born prematurely.
Exclusion Criteria
* Is not expected to live 6 weeks because of severe illness.
* Is having problems with blood pressure or is not urinating enough.
1 Day
5 Days
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Mirochnick M
Role: STUDY_CHAIR
Dankner D
Role: STUDY_CHAIR
Capparelli E
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States
Phoenix Childrens Hosp
Phoenix, Arizona, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
UCLA Med Ctr / Pediatric
Los Angeles, California, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States
Children's Hosp of Oakland
Oakland, California, United States
San Francisco Gen Hosp
San Francisco, California, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States
Univ of Florida Gainesville
Gainesville, Florida, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, United States
Univ of Miami (Pediatric)
Miami, Florida, United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States
Univ of Chicago Children's Hosp
Chicago, Illinois, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States
Children's Hosp of Boston
Boston, Massachusetts, United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, United States
Univ of Massachusetts Med School
Worcester, Massachusetts, United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States
Children's Hosp at Albany Med Ctr
Albany, New York, United States
Columbia Presbyterian Med Ctr
New York, New York, United States
Harlem Hosp Ctr
New York, New York, United States
Univ of Rochester Med Ctr
Rochester, New York, United States
State Univ of New York at Stony Brook
Stony Brook, New York, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States
Westchester Hosp
Valhalla, New York, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Med Univ of South Carolina
Charleston, South Carolina, United States
Children's Med Ctr of Dallas
Dallas, Texas, United States
Children's Hosp of the King's Daughters
Norfolk, Virginia, United States
Med College of Virginia
Richmond, Virginia, United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , Puerto Rico
Countries
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References
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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.
Other Identifiers
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11303
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 331
Identifier Type: -
Identifier Source: org_study_id