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

NCT01597180 | Withdrawn

• 1 other identifier: 12-0832
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

contraception; HIV; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Change in cervicovaginal fluide milieu

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

UNC Infectious Disease Clinic

Chapel Hill, North Carolina, 27516, United States

Location

Study Officials

• Gretchen S Stuart, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: May 11, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

US (1)