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Trial record 1 of 1 for:    Pharmacokinetics, pharmacodynamics, and genital tract viral shedding
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Pharmacokinetics, Pharmacodynamics and Cervicovaginal Lavage of Combined Oral Contraceptives and Raltegravir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01597180
Recruitment Status : Withdrawn (Could not find subjects who met all the enrollment criteria so the study was stopped.)
First Posted : May 11, 2012
Last Update Posted : March 5, 2014
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Gretchen Stuart, MD, University of North Carolina, Chapel Hill

Brief Summary:

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 or disease

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics, Pharmacodynamics and Genital Tract Viral Shedding in HIV+ Women Using Combined Oral Contraceptives and Raltegravir
Study Start Date : July 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Change in cervicovaginal fluide milieu

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01597180

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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.
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Principal Investigator: Gretchen S Stuart, MD University of North Carolina, Chapel Hill
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Responsible Party: Gretchen Stuart, MD, Associate Professor, Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill Identifier: NCT01597180    
Other Study ID Numbers: 12-0832
First Posted: May 11, 2012    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014
Keywords provided by Gretchen Stuart, MD, University of North Carolina, Chapel Hill: