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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
History of Changes
  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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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
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 May 16, 2013