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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00000830
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date November 2, 1999
First Posted Date August 31, 2001
Last Update Posted Date June 24, 2005
Study Start Date Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Intracellular Pharmacokinetics of Zidovudine Triphosphate in Maternal and Infant Cord Blood Mononuclear Cells.
Official Title Intracellular Pharmacokinetics of Zidovudine Triphosphate in Maternal and Infant Cord Blood Mononuclear Cells.
Brief Summary 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 Not Provided
Study Type Observational
Study Design Observational Model: Natural History
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • HIV Infections
  • Pregnancy
Intervention Not Provided
Study Groups/Cohorts Not Provided
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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: June¬†23,¬†2005)
24
Original Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria Not Provided
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00000830
Other Study ID Numbers ACTG 296
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators Not Provided
Investigators
Study Chair: Fridland A
Study Chair: Flynn P
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date March 1998