Status:
WITHDRAWN
Combined Oral Contraceptive (COC) Antiretroviral (ARV) Pharmacokinetics (PK) and Pharmacodynamics (PD) in Malawi
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Unintended Pregnancy
Eligibility:
FEMALE
21-35 years
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 antiret...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00998725
Start Date
November 1 2009
End Date
January 1 2011
Last Update
February 17 2017
Active Locations (1)
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1
UNC Project Malawi
Lilongwe, Malawi