Unintended Pregnancy
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
University of North Carolina, Chapel Hill
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of women who complete the study | 4 months |
Countries
Malawi
Outcome results
None listed