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

University of North Carolina (UNC)

Status: Withdrawn

Conditions: HIV; Pregnancy

Treatments: Other: Pharmacokinetics

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01251601

10-1691

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Raltegravir in Pregnancy

Description:

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

Treatment:

Other: Pharmacokinetics