Pharmacokinetics of Raltegravir During Third Trimester Pregnancy and Post-Partum

HIV Infections Clinical Trial

Official title:

Pharmacokinetics of Raltegravir During Third Trimester Pregnancy and Post-Partum

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00689910
• Other study ID #: PK of Ral in Pregnant Women
• Status: Withdrawn
• Phase: N/A
• First received: June 2, 2008
• Last updated: March 28, 2012
• Start date: February 2008

Study information

• Verified date: March 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This study will evaluate the pharmacokinetic disposition of raltegravir in pregnant HIV-1 infected women. These results will be compared to pharmacokinetic data obtained following pregnancy as well as to studies previously carried out in nonpregnant women and male patients. By determining the disposition characteristics for this specific patient population, antiretroviral (ARV) dosing can be optimized during pregnancy. Appropriate dosing is necessary to minimize adverse effects, slow progression of disease, and further reduce the risk for vertical transmission. Data will also be obtained on genital tract penetration and placenta transfer of raltegravir to the newborn.

The subjects enrolled in this study will take an antiretroviral based regimen containing raltegravir twice daily both during and after their pregnancy. The specific regimen will be chosen by their own primary care provider based on their antiretroviral history and resistance testing. They will undergo a series of blood sampling for pharmacokinetic analysis over 12 hours on two occasions; a) during their 3rd trimester and b) approximately 3 months postpartum. Concentrations of raltegravir in the infant will be assessed by cord and infant blood sample at delivery and a blood sample at approximately 3 months of age.

Hypothesis: The pharmacokinetic exposure of raltegravir as measured by the 12 hour area under the plasma concentration versus time curve (AUC0-12h) during third trimester pregnancy is similar to the AUC0-12h estimated three months post-partum.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Female, 16 years old or older

• Pregnant, at least 14 weeks gestation in order to initiate raltegravir treatment if decided by their pregnancy health care provider. The first pharmacokinetic study visit occurs no sooner than 26 weeks gestation (3rd trimester)

• Normal fetal heart motion by ultrasound, vital signs and brief physical exam as conducted by their primary pregnancy health care provider within two weeks of study entry (part of their standard prenatal care)

• Intolerance or resistance to at least two classes of antiretroviral agents

• Availability of a raltegravir-optimized background regimen based on referring provider's selection and resistance testing

• English or Spanish speaking

Exclusion Criteria:

• Inability to follow study protocol or drug administration

• Women who are planning to breastfeed (this is not recommended for HIV-infected women to reduce HIV transmission to the baby)

• Women unable to sign informed consent

• Women with a history of anaphylaxis or other life threatening adverse event associated with antiretroviral therapy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
United States	East Bay AIDS Center	Oakland	California
United States	UC Davis	Sacramento	California
United States	San Francisco General Hospital	San Francisco	California
United States	UC San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States,