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This study has been withdrawn prior to enrollment.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.)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Gretchen Stuart, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01597180
First received: May 9, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition
HIV

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 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)
  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders 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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597180

Locations
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.
Investigators
Principal Investigator: Gretchen S Stuart, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

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

Keywords provided by University of North Carolina, Chapel Hill:
contraception
HIV
pharmacokinetics
pharmacodynamics

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on August 21, 2014