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

NCT ID: NCT01597180

Last Updated: 2014-03-05

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-03-31

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.

Conditions

HIV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Gretchen Stuart, MD

Associate Professor, Department of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gretchen S Stuart, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

UNC Infectious Disease Clinic

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

12-0832

Identifier Type: -

Identifier Source: org_study_id