A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women.

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000855

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

35

Expected to finish

2000-02-01

Last updated by the study team

2021-10-28

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.