Clinical trial NCT00998725: Combined Oral Contraceptive (COC) Antiretroviral (ARV) Pharmacokinetics (PK) and Pharmacodynamics (PD) in Malawi
Official title: A Pilot Study of Pharmacokinetic and Pharmacodynamic Activity of LoFemenal
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Unintended Pregnancy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-10-20
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 9 women with known HIV status who have regular monthly menses.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of women who complete the study
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: UNC Project Malawi
Study officials:
affiliation: University of North Carolina
name: Gretchen S Stuart, MD, MPHTM
role: PRINCIPAL_INVESTIGATOR
References: