Intracellular Pharmacokinetics of Zidovudine Triphosphate in Maternal and Infant Cord Blood Mononuclear Cells.

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000830

Purpose

To determine the levels of zidovudine triphosphate ( AZT-TP ) in maternal and fetal cord blood mononuclear cells. To determine the ratio of AZT-TP to endogenous nucleoside triphosphate levels in maternal and fetal cells. To determine the extent of drug transfer through the feto/placental unit.

Condition
HIV Infections Pregnancy

Study Type:	Observational
Study Design:	Natural History
Official Title:	Intracellular Pharmacokinetics of Zidovudine Triphosphate in Maternal and Infant Cord Blood Mononuclear Cells.

Resource links provided by NLM:

MedlinePlus related topics: AIDS

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:

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000830

Locations

United States, New Jersey
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
United States, New York
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Mount Sinai Med Ctr / Pediatrics
New York, New York, United States, 10029
United States, Tennessee
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States, 381052794
Regional Med Ctr at Memphis
Memphis, Tennessee, United States, 38103
Puerto Rico
San Juan City Hosp
San Juan, Puerto Rico, 009367344

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:	Fridland A
Study Chair:	Flynn P

More Information

Publications:

Rodman JH, Flynn PM, Robbins BL, Blanchard S, Jimenez E, Rodriguez J, Fridland A. Zidovudine pharmacokinetics and intracellular pharmacology of zidovudine in HIV-infected women and newborn infants. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:146 (abstract no 419)

Study ID Numbers:	ACTG 296
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000830 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Antimetabolites
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Zidovudine
Antiviral Agents
Immunologic Deficiency Syndromes

Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
3'-azido-3'-deoxythymidine 5'-triphosphate
Retroviridae Infections

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Zidovudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
3'-azido-3'-deoxythymidine 5'-triphosphate
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on July 02, 2009