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

Unintended Pregnancy Clinical Trial

— COCARVPK  

Official title:

A Pilot Study of Pharmacokinetic and Pharmacodynamic Activity of LoFemenal

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00998725
• Other study ID #: 08-1500
• Secondary ID: AI050410 (#9p30)
• Status: Withdrawn
• Phase: N/A
• First received: October 16, 2009
• Last updated: February 15, 2017
• Start date: November 2009
• Est. completion date: January 2011

Study information

• Verified date: February 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Unintended Pregnancy

Locations

Country	Name	City	State
Malawi	UNC Project Malawi	Lilongwe

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of women who complete the study		4 months