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

HIV Clinical Trial

Official title:

Pharmacokinetics, Pharmacodynamics and Genital Tract Viral Shedding in HIV+ Women Using Combined Oral Contraceptives and Raltegravir

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01597180
• Other study ID #: 12-0832
• Status: Withdrawn
• Phase: N/A
• First received: May 9, 2012
• Last updated: March 4, 2014
• Start date: July 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV

Locations

Country	Name	City	State
United States	UNC Infectious Disease Clinic	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cervicovaginal fluide milieu