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

This study has been completed.

First Received: November 2, 1999 Last Updated: July 29, 2008 History of Changes

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000855

Purpose

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.

Condition	Intervention
HIV Infections	Drug: Zidovudine

Study Type:	Interventional
Study Design:	Treatment, Open Label, Pharmacokinetics Study
Official Title:	The Safety, Tolerance, and Pharmacokinetics of Zidovudine in Premature Infants Exposed to HIV.

Resource links provided by NLM:

MedlinePlus related topics: AIDS Premature Babies

Drug Information available for: Zidovudine

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:

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.

Eligibility

Ages Eligible for Study:	up to 5 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000855

Show 36 Study Locations

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:	Mirochnick M
Study Chair:	Dankner D
Study Chair:	Capparelli E

More Information

Additional Information:

Click here for more information about Zidovudine This link exits the ClinicalTrials.gov site

Publications:

Capparelli EV, Mirochnick M, Dankner WM, Blanchard S, Mofenson L, McSherry GD, Gay H, Ciupak G, Smith B, Connor JD. Pharmacokinetics and tolerance of zidovudine in preterm infants. J Pediatr. 2003 Jan;142(1):47-52.

Study ID Numbers:	ACTG 331
Study First Received:	November 2, 1999
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00000855 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Zidovudine
Anti-HIV Agents

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Zidovudine
Enzyme Inhibitors
Infection

Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 05, 2009