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 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
Scroll for more (26 remaining)Univ of Alabama at Birmingham - Pediatric🇺🇸Birmingham, Alabama, United States