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

This study has been completed.
Sponsor:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00998725
First received: October 16, 2009
Last updated: June 28, 2011
Last verified: June 2011
  Purpose

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 Phase
Unintended Pregnancy
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study of Pharmacokinetic and Pharmacodynamic Activity of LoFemenal

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Number of women who complete the study [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: November 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV+ARV+
HIV+ARV-
HIV negative

  Eligibility

Ages Eligible for Study:   21 Years to 35 Years
Genders 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.

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.
  Contacts and Locations
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

Locations
Malawi
UNC Project Malawi
Lilongwe, Malawi
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Gretchen S Stuart, MD, MPHTM University of North Carolina
  More Information

No publications provided

Responsible Party: Gretchen S. Stuart, MD, MPHTM Assistant Professor of Obstetrics and Gynecology, University of North Carolina at Chapel Hill
ClinicalTrials.gov Identifier: NCT00998725     History of Changes
Other Study ID Numbers: 08-1500, #9p30, AI050410
Study First Received: October 16, 2009
Last Updated: June 28, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014