Combined Oral Contraceptive (COC) Antiretroviral (ARV) Pharmacokinetics (PK) and Pharmacodynamics (PD) in Malawi (COCARVPK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00998725
Recruitment Status : Withdrawn
First Posted : October 20, 2009
Last Update Posted : February 17, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Gretchen Stuart, MD, University of North Carolina, Chapel Hill

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.

Condition or disease
Unintended Pregnancy

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study of Pharmacokinetic and Pharmacodynamic Activity of LoFemenal
Study Start Date : November 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

HIV negative

Primary Outcome Measures :
  1. Number of women who complete the study [ Time Frame: 4 months ]

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Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
9 women with known HIV status who have regular monthly menses.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00998725

UNC Project Malawi
Lilongwe, Malawi
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Merck Sharp & Dohme Corp.
Principal Investigator: Gretchen S Stuart, MD, MPHTM University of North Carolina

Responsible Party: Gretchen Stuart, MD, Associate Professor, University of North Carolina, Chapel Hill Identifier: NCT00998725     History of Changes
Other Study ID Numbers: 08-1500
AI050410 (#9p30) ( Other Identifier: Merck )
First Posted: October 20, 2009    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs