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

University of North Carolina, Chapel Hill

Overview

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.

Study Type

OBSERVATIONAL

Conditions

HIV Pregnancy

Interventions

PharmacokineticsOTHER

Up to three 12 hour PK sampling sessions, one in the second trimester, one in the third trimester and one post partum

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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