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

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study of Pharmacokinetic and Pharmacodynamic Activity of LoFemenal

Conditions
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Unintended Pregnancy

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV+ARV+<br> | |
| HIV+ARV-<br> | |
| HIV negative<br> | |

What is the study measuring?
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Primary Outcome Measures

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