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

NCT ID: NCT00000830

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections Pregnancy

Study Design

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Observational Model Type

NATURAL_HISTORY

Eligibility Criteria

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Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Principal Investigators

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Fridland A

Role: STUDY_CHAIR

Flynn P

Role: STUDY_CHAIR

Locations

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Univ of Medicine & Dentistry of New Jersey / Univ Hosp

Newark, New Jersey, United States

Site Status

Bellevue Hosp / New York Univ Med Ctr

New York, New York, United States

Site Status

Mount Sinai Med Ctr / Pediatrics

New York, New York, United States

Site Status

Regional Med Ctr at Memphis

Memphis, Tennessee, United States

Site Status

Saint Jude Children's Research Hosp of Memphis

Memphis, Tennessee, United States

Site Status

San Juan City Hosp

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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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)

Reference Type BACKGROUND

Other Identifiers

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ACTG 296

Identifier Type: -

Identifier Source: org_study_id