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WITHDRAWN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

Active Locations (0)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 0 (0 locations)

No Results Found

We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.