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

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ClinicalTrials.gov Identifier: NCT01251601
Recruitment Status : Withdrawn (Withdrawn due to inability to recruit eligible participants)
First Posted : December 2, 2010
Last Update Posted : February 2, 2012
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Angela Kashuba, PharmD, University of North Carolina, Chapel Hill

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment
HIV Pregnancy Other: Pharmacokinetics

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Time Perspective: Prospective
Official Title: The Effect of Pregnancy on the Pharmacokinetics of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters
Study Start Date : November 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: December 2, 2010    Key Record Dates
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