Levels of Raltegravir in the Female Genital Tissue

NCT01327482 | Completed Results

• 1 other identifier: 38681-D
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV

Keywords

Raltegravir; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Tissue Raltegravir Concentrations

  Mean trough concentration from all three days. Tissue concentrations are measured from cervical biopsy homogenate using a mass-spectroscopy-based method.

  7, 14, 21 days

Secondary Outcomes (1)

• Plasma Raltegravir Concentrations

  7, 14, 21 days

Study Arms (1)

All

EXPERIMENTAL

All patients were part of the intervention arm, as this was a pharmacokinetic study. All women took Raltegravir 400mg orally, twice daily for 3 weeks.

Drug: Raltegravir

Interventions

Raltegravir DRUG

Dosage: 400mg/PO (by mouth) Frequency: Twice daily Duration: During course of menstrual cycle (28 days)

Also known as: Isentress

All

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Washington, Clinical Research Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Interventions

Raltegravir Potassium

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Caroline Mitchell
• Organization: Massachusetts General Hospital

caroline.mitchell@mgh.harvard.edu

617-724-2182

Study Officials

• Caroline Mitchell, MD

  University Washington

  PRINCIPAL INVESTIGATOR

• Lisa Frenkel, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: April 1, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2012
• Last Updated: December 19, 2014
• Results First Posted: December 19, 2014

Record last verified: 2014-12

Locations

US (1)