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This study has been withdrawn prior to enrollment.

(Withdrawn due to inability to recruit eligible participants)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

History of Changes

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:

Drug Information available for: Raltegravir Raltegravir potassium

U.S. FDA Resources

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


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

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


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

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

ClinicalTrials.gov processed this record on August 18, 2017

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