Pharmacokinetics, Pharmacodynamics and Cervicovaginal Lavage of Combined Oral Contraceptives and Raltegravir

March 4, 2014 updated by: Gretchen Stuart, MD, University of North Carolina, Chapel Hill

Pharmacokinetics, Pharmacodynamics and Genital Tract Viral Shedding in HIV+ Women Using Combined Oral Contraceptives and Raltegravir

The purpose of this trial is to learn about potential interactions between raltegravir and a birth control pill in HIV+ women. The investigators plan to enroll HIV+ women who are on steady state raltegravir containing highly active antiretroviral therapy (HAART), ages 20-40, inclusive, who report regular monthly menses.

The investigators will investigate drug interactions of raltegravir, ethinyl estradiol (EE) and levonorgestrel (LNG). All women will be receiving raltegravir as part of their regular medical care. Women will be enrolled in the study for approximately 8 months.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • UNC Infectious Disease Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women recruited from an infectious diseases clinic in Chapel Hill, NC.

Description

Inclusion Criteria:

  • Women between 20-40 years of age with regular monthly menses
  • If over age 35 then must not use tobacco
  • Negative pregnancy test
  • No known allergy to raltegravir
  • No known history of phenylketonuria
  • Undetectable HIV viral load
  • No active liver disease as determined by medical history and normal AST and ALT
  • No history of hepatic adenomas, carcinomas or benign liver tumors
  • Ho history of thrombophlebitis of thromboembolic disease
  • No history of deep vein thrombosis
  • No history of cerebral vascular or coronary artery disease
  • No known or suspected carcinoma of the breast
  • No undiagnosed abnormal genital bleeding
  • Not taking concomitant CYP 450 inducing medications such as anti-seizure medications
  • No use of oral contraceptives, depot-medroxyprogesterone acetate, contraceptive ring or patch within two months of screening
  • No cholestatic jaundice of pregnancy or jaundice with prior contraceptive pill use
  • Has used raltegravir prior to screening
  • Has no history of malignancy of the genital tract (e.g. cervical cancer, ovarian cancer, endometrial cancer)
  • Must not have had an abnormal pap test defined without resolution in the last 18 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in cervicovaginal fluide milieu

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Gretchen S Stuart, MD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

May 9, 2012

First Submitted That Met QC Criteria

May 10, 2012

First Posted (Estimate)

May 11, 2012

Study Record Updates

Last Update Posted (Estimate)

March 5, 2014

Last Update Submitted That Met QC Criteria

March 4, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12-0832

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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