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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01251601

Enrollment

Registered

2010-12-02

Start date

2010-11-30

Completion date

2011-09-30

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Pregnancy

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.

Interventions

OTHERPharmacokinetics

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

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 99 Years

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026