Combined Oral Contraceptive (COC) Antiretroviral (ARV) Pharmacokinetics (PK) and Pharmacodynamics (PD) in Malawi (COCARVPK)

A Pilot Study of Pharmacokinetic and Pharmacodynamic Activity of LoFemenal

The purpose of this research study is to learn about the birth control pill called LoFemenal in HIV+ and HIV negative women who live in Malawi. This is a pilot study to determine the effect of antiretroviral therapy on the pharmacokinetics of the most commonly used oral contraceptive in HIV+ women; and to measure ovulation suppression in women taking the oral contraceptive pill and antiretroviral therapy at the same time. Nine women will be enrolled and will be followed for a total of 4 months.

Study Overview

• Status: Withdrawn
• Conditions: Unintended Pregnancy

• Study Type: Observational

Contacts and Locations

Study Locations

• Malawi
  • Lilongwe, Malawi
    • UNC Project Malawi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

9 women with known HIV status who have regular monthly menses.

Description

Inclusion Criteria:

• Can provide informed consent
• Women ages 21-35 with known HIV status
• If HIV negative must have had an HIV test within the last 3 months
• Intend to stay in Lilongwe region for the duration of the study
• Desire to prevent pregnancy for at least the next six months
• Desires to use LoFemenal for contraception
• Has no known history of infertility
• Has intact uterus and at least one ovary
• Has regular monthly menses defined by menses occurring every 21-35 days
• Has not used another form of systemic hormonal contraception within the last six months.
• Has no contraindications to the combined oral contraceptive LoFemenal which include; any thrombophlebitis or thromboembolic disorders; cerebral-vascular or coronary-artery disease (current or history); thrombogenic valvulopathies; thrombogenic rhythm disorders; major surgery with prolonged immobilization; diabetes with vascular involvement; headaches with focal neurological symptoms; uncontrolled hypertension; known or suspected carcinoma of the breast or personal history of breast cancer; carcinoma of the endometrium or other known or suspected estrogen dependent neoplasia; undiagnosed abnormal genital bleeding; cholestatic jaundice of pregnancy or jaundice with prior pill use; hepatic adenomas or carcinomas or active lever disease, as long as liver function has not returned to normal; known or suspected pregnancy.

Exclusion Criteria:

• Hemoglobin < 10 mg/dL.
• Body mass index < 18.6 kg/m^2.
• Using any drugs known to interfere with cytochrome P450 system (such as rifampicin, phenytoin, carbamezapine, among others)
• In the opinion of the PI or study staff the individual cannot complete the study
• Cannot be adherent to other medications.

Additional inclusion criteria for the 3 HIV+ women on antiretroviral therapy:

• Must be on antiretroviral therapy which includes nevirapine for at least three consecutive months immediately prior to enrollment into the study
• Must report adherence to medication and medical visits
• Must be willing to use a barrier or backup method of contraception.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
HIV negative
HIV+ARV+
HIV+ARV-

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of women who complete the study	4 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Gretchen S Stuart, MD, MPHTM, University of North Carolina

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: October 16, 2009
• First Submitted That Met QC Criteria: October 19, 2009
• First Posted (Estimate): October 20, 2009

Study Record Updates

• Last Update Posted (Actual): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 15, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 08-1500; AI050410 (#9p30) (Other Identifier: Merck)