Levels of Raltegravir in the Female Genital Tissue

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

This study is an investigation of the pharmacokinetics of raltegravir in the tissue of the female genital tract to determine if twice-daily dosing of 400mg achieves adequate drug levels to prevent viral integration of HIV-1. The study will also assess whether drug levels change in the tissue across the different phases of the menstrual cycle.

• Hypothesis #1: Twice daily dosing with raltegravir 400mg will result in intracellular concentrations that should be sufficient to suppress HIV-1 replication throughout the menstrual cycle.

• Hypothesis #2: Intracellular genital raltegravir peaks will be lower and troughs higher compared to extracellular concentrations in the plasma and PMBCs (peripheral blood mononuclear cells).

• Hypothesis #3: Intracellular raltegravir concentrations will be slightly lower during the luteal phase of the menstrual cycle due to cellular pumps such as p-glycoprotein, which are present in higher numbers during periods of high progesterone.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Raltegravir Potassium

Criteria

Inclusion Criteria

Volunteers must be:

• Over 18 years of age.

• Willing to abstain from sexual intercourse during course of study.

• Able to commit to follow-up visit schedule.

• Willing to abstain from use of vaginal medications or creams 48 hours prior to follow-up visits.

• Willing and able to provide informed consent.

Exclusion Criteria

Volunteers will not be eligible for the study if they:

• Are over 50 years of age.

• Are pregnant, attempting to become pregnant, or breast-feeding.

• Have irregular menstrual bleeding.

• Are using a hormonal form of birth control.

• Have abnormal liver/kidney function test results at screening visit.

• Have HIV-positive test result at screening visit.