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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
ClinicalTrials.gov processed this record on March 31, 2015
||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