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

This study has been withdrawn prior to enrollment.
(Could not find subjects who met all the enrollment criteria so the study was stopped.)
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Gretchen Stuart, MD, University of North Carolina, Chapel Hill Identifier:
First received: May 9, 2012
Last updated: March 4, 2014
Last verified: March 2014

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 Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics, Pharmacodynamics and Genital Tract Viral Shedding in HIV+ Women Using Combined Oral Contraceptives and Raltegravir

Resource links provided by NLM:

Further study details as provided by Gretchen Stuart, MD, University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Change in cervicovaginal fluide milieu

Enrollment: 0
Study Start Date: July 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women recruited from an infectious diseases clinic in Chapel Hill, NC.

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.
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Please refer to this study by its identifier: NCT01597180

United States, North Carolina
UNC Infectious Disease Clinic
Chapel Hill, North Carolina, United States, 27516
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Merck Sharp & Dohme Corp.
Principal Investigator: Gretchen S Stuart, MD University of North Carolina, Chapel Hill
  More Information

Responsible Party: Gretchen Stuart, MD, Associate Professor, Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill Identifier: NCT01597180     History of Changes
Other Study ID Numbers: 12-0832
Study First Received: May 9, 2012
Last Updated: March 4, 2014

Keywords provided by Gretchen Stuart, MD, University of North Carolina, Chapel Hill:

Additional relevant MeSH terms:
Contraceptive Agents
Raltegravir Potassium
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Contraceptive Agents, Female processed this record on September 21, 2017