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This study has been withdrawn prior to enrollment.
(Withdrawn due to inability to recruit eligible participants)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:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Angela Kashuba, PharmD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01251601
First received: November 30, 2010
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
HIV
Pregnancy
Other: Pharmacokinetics

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Effect of Pregnancy on the Pharmacokinetics of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Enrollment: 0
Study Start Date: November 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Raltegravir in Pregnancy
HIV positive pregnant women currently on raltegravir as part of combination antiretroviral therapy
Other: Pharmacokinetics
Up to three 12 hour PK sampling sessions, one in the second trimester, one in the third trimester and one post partum

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be recruited by their HIV clinic providers

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251601

Sponsors and Collaborators
University of North Carolina, Chapel Hill
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Angela DM Kashuba, PharmD UNC Chapel Hill
Principal Investigator: Kristine B Patterson, MD UNC Chapel Hill
  More Information

No publications provided

Responsible Party: Angela Kashuba, PharmD, Professor, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01251601     History of Changes
Other Study ID Numbers: 10-1691
Study First Received: November 30, 2010
Last Updated: January 31, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 19, 2014