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The Effect of Pregnancy on the PK of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters

This study has been withdrawn prior to enrollment.
(Withdrawn due to inability to recruit eligible participants)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01251601
First Posted: December 2, 2010
Last Update Posted: February 2, 2012
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.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Angela Kashuba, PharmD, University of North Carolina, Chapel Hill
November 30, 2010
December 2, 2010
February 2, 2012
November 2010
September 2011   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01251601 on ClinicalTrials.gov Archive Site
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The Effect of Pregnancy on the PK of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters
The Effect of Pregnancy on the Pharmacokinetics of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters
The purpose of this study is to determine whether pregnancy affects the blood concentrations of raltegravir by comparing the second trimester and third trimester drug concentrations with post partum.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients will be recruited by their HIV clinic providers
  • HIV
  • Pregnancy
Other: Pharmacokinetics
Up to three 12 hour PK sampling sessions, one in the second trimester, one in the third trimester and one post partum
Raltegravir in Pregnancy
HIV positive pregnant women currently on raltegravir as part of combination antiretroviral therapy
Intervention: Other: Pharmacokinetics
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2011
September 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV Infected
  • Pregnant
  • At least 18 years of age
  • Planning to initiate or currently received raltegravir as part of an antiretroviral regimen with plans to continue at least 8-10 weeks post partum

Exclusion Criteria:

  • Less than 18 years of age
  • Hemoglobin <9 g/dL or Hematocrit <27.3 at screening
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01251601
10-1691
No
Not Provided
Not Provided
Angela Kashuba, PharmD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Merck Sharp & Dohme Corp.
Principal Investigator: Angela DM Kashuba, PharmD UNC Chapel Hill
Principal Investigator: Kristine B Patterson, MD UNC Chapel Hill
University of North Carolina, Chapel Hill
January 2012