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

HIV Infections Clinical Trial

Official title:

The Safety, Tolerance, and Pharmacokinetics of Zidovudine in Premature Infants Exposed to HIV.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000855
• Other study ID #: ACTG 331
• Secondary ID: 11303
• Status: Completed
• Phase: N/A
• Est. completion date: February 2000

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 2000
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Days

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Zidovudine

Locations

Country	Name	City	State
Puerto Rico	Univ of Puerto Rico / Univ Children's Hosp AIDS	San Juan
United States	Children's Hosp at Albany Med Ctr	Albany	New York
United States	Emory Univ Hosp / Pediatrics	Atlanta	Georgia
United States	Univ of Alabama at Birmingham - Pediatric	Birmingham	Alabama
United States	Boston City Hosp / Pediatrics	Boston	Massachusetts
United States	Children's Hosp of Boston	Boston	Massachusetts
United States	Med Univ of South Carolina	Charleston	South Carolina
United States	Univ of Chicago Children's Hosp	Chicago	Illinois
United States	Univ of Illinois College of Medicine / Pediatrics	Chicago	Illinois
United States	Children's Med Ctr of Dallas	Dallas	Texas
United States	Duke Univ Med Ctr	Durham	North Carolina
United States	Univ of Florida Gainesville	Gainesville	Florida
United States	Division of Inf Diseases/ Indiana Univ Hosp	Indianapolis	Indiana
United States	Univ of Mississippi Med Ctr	Jackson	Mississippi
United States	Univ of Florida Health Science Ctr / Pediatrics	Jacksonville	Florida
United States	UCSD Med Ctr / Pediatrics / Clinical Sciences	La Jolla	California
United States	Harbor - UCLA Med Ctr / UCLA School of Medicine	Los Angeles	California
United States	Los Angeles County - USC Med Ctr	Los Angeles	California
United States	UCLA Med Ctr / Pediatric	Los Angeles	California
United States	Univ of Miami (Pediatric)	Miami	Florida
United States	Univ of Miami / Jackson Memorial Hosp	Miami	Florida
United States	Columbia Presbyterian Med Ctr	New York	New York
United States	Harlem Hosp Ctr	New York	New York
United States	Univ of Medicine & Dentistry of New Jersey / Univ Hosp	Newark	New Jersey
United States	Children's Hosp of the King's Daughters	Norfolk	Virginia
United States	Children's Hosp of Oakland	Oakland	California
United States	Phoenix Childrens Hosp	Phoenix	Arizona
United States	Med College of Virginia	Richmond	Virginia
United States	Univ of Rochester Med Ctr	Rochester	New York
United States	San Francisco Gen Hosp	San Francisco	California
United States	UCSF / Moffitt Hosp - Pediatric	San Francisco	California
United States	Children's Hospital & Medical Center / Seattle ACTU	Seattle	Washington
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	Univ of Massachusetts Med School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

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. — View Citation