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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This study has been withdrawn prior to enrollment.
(Withdrawn due to inability to recruit eligible participants)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
  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 Angela Kashuba, PharmD, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 30, 2010
First Posted: December 2, 2010
Last Update Posted: February 2, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action