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

NCT00998725 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2017-02-17

No results posted yet for this study

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

Sponsors & Collaborators

Principal Investigators

  • Gretchen S Stuart, MD, MPHTM · University of North Carolina

Eligibility

Min Age
21 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • Malawi

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00998725 on ClinicalTrials.gov