Combined Oral Contraceptive (COC) Antiretroviral (ARV) Pharmacokinetics (PK) and Pharmacodynamics (PD) in Malawi (COCARVPK)
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ClinicalTrials.gov Identifier: NCT00998725
Recruitment Status :
First Posted : October 20, 2009
Last Update Posted : February 17, 2017
University of North Carolina, Chapel Hill
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Gretchen Stuart, MD, University of North Carolina, Chapel Hill
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.
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Ages Eligible for Study:
21 Years to 35 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
9 women with known HIV status who have regular monthly menses.
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.
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.