Status:
WITHDRAWN
The Effect of Pregnancy on the PK of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV
Pregnancy
Eligibility:
FEMALE
18-99 years
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.
Eligibility Criteria
Inclusion
- 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
- Less than 18 years of age
- Hemoglobin \<9 g/dL or Hematocrit \<27.3 at screening
Key Trial Info
Start Date :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01251601
Start Date
November 1 2010
End Date
September 1 2011
Last Update
February 28 2024
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