Search / Trial NCT00000855

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 December 09, 2024

Completed

Keywords

Zidovudine Anti Hiv Agents

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.

Trial Officials

Mirochnick M

Study Chair

Dankner D

Study Chair

Capparelli E

Study Chair

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.

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

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

Similar Trials