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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This study has been withdrawn prior to enrollment.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.)
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

May 9, 2012
March 4, 2014
July 2012
March 2014   (final data collection date for primary outcome measure)
Change in cervicovaginal fluide milieu
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Complete list of historical versions of study NCT01597180 on ClinicalTrials.gov Archive Site
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Pharmacokinetics, Pharmacodynamics and Cervicovaginal Lavage of Combined Oral Contraceptives and Raltegravir
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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

HIV
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2014
March 2014   (final data collection date for primary outcome measure)

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.
Female
20 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01597180
12-0832
No
Gretchen Stuart, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Merck Sharp & Dohme Corp.
Principal Investigator: Gretchen S Stuart, MD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP