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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Pregnancy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Raltegravir in Pregnancy

HIV positive pregnant women currently on raltegravir as part of combination antiretroviral therapy

Pharmacokinetics

Intervention Type OTHER

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

Interventions

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Pharmacokinetics

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

Intervention Type OTHER

Eligibility Criteria

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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