Combined Oral Contraceptive (COC) Antiretroviral (ARV) Pharmacokinetics (PK) and Pharmacodynamics (PD) in Malawi (COCARVPK)
This study has been completed.
Information provided by:
University of North Carolina, Chapel Hill
First received: October 16, 2009
Last updated: June 28, 2011
Last verified: June 2011
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.
||Observational Model: Cohort
Time Perspective: Prospective
||A Pilot Study of Pharmacokinetic and Pharmacodynamic Activity of LoFemenal
Primary Outcome Measures:
- Number of women who complete the study [ Time Frame: 4 months ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2011 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||21 Years to 35 Years
|Genders 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998725
|UNC Project Malawi
|Lilongwe, Malawi |
University of North Carolina, Chapel Hill
||Gretchen S Stuart, MD, MPHTM
||University of North Carolina
No publications provided
||Gretchen S. Stuart, MD, MPHTM Assistant Professor of Obstetrics and Gynecology, University of North Carolina at Chapel Hill
History of Changes
|Other Study ID Numbers:
||08-1500, #9p30, AI050410
|Study First Received:
||October 16, 2009
||June 28, 2011
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 10, 2014
Contraceptives, Oral, Combined
Contraceptive Agents, Female
Reproductive Control Agents
Physiological Effects of Drugs