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

Withdrawn

• Conditions: HIV; Pregnancy
• Interventions: Other: Pharmacokinetics

• Registration Number: NCT01251601
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-30
• Study First Submitted QC: 2010-12-01
• Study First Posted: 2010-12-02
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-01
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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Exclusion Criteria

• Less than 18 years of age
• Hemoglobin <9 g/dL or Hematocrit <27.3 at screening

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Raltegravir in Pregnancy	Pharmacokinetics	HIV positive pregnant women currently on raltegravir as part of combination antiretroviral therapy