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

NCT00998725 | Withdrawn

• 2 other identifiers: 08-1500AI050410 (#9p30)
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Unintended Pregnancy

Outcome Measures

Primary Outcomes (1)

• Number of women who complete the study

  4 months

Study Arms (3)

HIV+ARV+

HIV+ARV-

HIV negative

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

9 women with known HIV status who have regular monthly menses.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

UNC Project Malawi

Lilongwe, Malawi

Location

Study Officials

• Gretchen S Stuart, MD, MPHTM

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 16, 2009
• First Posted: October 20, 2009
• Study Start: November 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: February 17, 2017

Record last verified: 2017-02

Locations

MA (1)