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

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.