A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women.
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 14, 2025
Completed
Keywords
ClinConnect Summary
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 d...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- 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.
- • Exclusion Criteria
- 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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
San Francisco, California, United States
Seattle, Washington, United States
La Jolla, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Oakland, California, United States
San Francisco, California, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Albany, New York, United States
New York, New York, United States
New York, New York, United States
Stony Brook, New York, United States
Syracuse, New York, United States
Valhalla, New York, United States
Durham, North Carolina, United States
Charleston, South Carolina, United States
Dallas, Texas, United States
San Juan, , Puerto Rico
Newark, New Jersey, United States
Worcester, Massachusetts, United States
Jacksonville, Florida, United States
Rochester, New York, United States
Miami, Florida, United States
Birmingham, Alabama, United States
Gainesville, Florida, United States
Jackson, Mississippi, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Indianapolis, Indiana, United States
Phoenix, Arizona, United States
Patients applied
Trial Officials
Mirochnick M
Study Chair
Dankner D
Study Chair
Capparelli E
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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