A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women.
- Conditions
- HIV Infections
- Registration Number
- NCT00000855
- 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.
- Detailed Description
In the preliminary group of premature infants, those receiving q 6h dosing had an average trough concentration of 7.3 uM (18%). However, the premature infants in the preliminary pharmacokinetic study did not have long term follow-up to assess toxicity. Due to the potential for altered ZDV pharmacokinetics and increased toxicity in this population, an evaluation of ZDV pharmacokinetics in premature infants is proposed.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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 (36)
Univ of Illinois College of Medicine / Pediatrics
🇺🇸Chicago, Illinois, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
🇺🇸Newark, New Jersey, United States
State Univ of New York at Stony Brook
🇺🇸Stony Brook, New York, United States
Children's Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
Univ of Miami / Jackson Memorial Hosp
🇺🇸Miami, Florida, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Univ of Miami (Pediatric)
🇺🇸Miami, Florida, United States
Boston City Hosp / Pediatrics
🇺🇸Boston, Massachusetts, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
UCSF / Moffitt Hosp - Pediatric
🇺🇸San Francisco, California, United States
Phoenix Childrens Hosp
🇺🇸Phoenix, Arizona, United States
Univ of Alabama at Birmingham - Pediatric
🇺🇸Birmingham, Alabama, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
🇺🇸La Jolla, California, United States
Los Angeles County - USC Med Ctr
🇺🇸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
Univ of Florida Health Science Ctr / Pediatrics
🇺🇸Jacksonville, Florida, United States
Division of Inf Diseases/ Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Children's Hosp of Boston
🇺🇸Boston, Massachusetts, United States
Univ of Mississippi Med Ctr
🇺🇸Jackson, Mississippi, United States
Univ of Massachusetts Med School
🇺🇸Worcester, Massachusetts, United States
Children's Hosp at Albany Med Ctr
🇺🇸Albany, New York, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
🇺🇸Syracuse, New York, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Harlem Hosp Ctr
🇺🇸New York, New York, United States
Westchester Hosp
🇺🇸Valhalla, New York, United States
Univ of Rochester Med Ctr
🇺🇸Rochester, New York, United States
Children's Hosp of the King's Daughters
🇺🇸Norfolk, 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
UCLA Med Ctr / Pediatric
🇺🇸Los Angeles, California, United States
Emory Univ Hosp / Pediatrics
🇺🇸Atlanta, Georgia, United States
Univ of Chicago Children's Hosp
🇺🇸Chicago, Illinois, United States
Univ of Florida Gainesville
🇺🇸Gainesville, Florida, United States
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States
Med College of Virginia
🇺🇸Richmond, Virginia, United States