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A Pharmacokinetic Evaluation of Increased Dose Levonorgestrel Implant and Efavirenz-Based Antiretroviral Therapy In HIV-Infected Ugandan Women
The purpose of this study is to determine whether increasing the dose of the levonorgestrel subdermal contraceptive implant will overcome a detrimental drug-drug interaction with efavirenz based antiretroviral therapy.
The investigators research team recently demonstrated that combined use of efavirenz (EFV) based antiretroviral therapy (ART), the only preferred first-line ART regimen in low and middle income countries, with a levonorgestrel (LNG)-releasing implant for one year reduced LNG plasma concentrations by approximately 50% compared to women not on ART. Importantly, the investigators also observed three unintended pregnancies (15%) in the investigators study group of women on EFV-based ART plus the LNG implant, in contrast to the \<1% expected failure rate of the implant for women without drug interactions. This study will determine if increasing the dose of the LNG-releasing subdermal implant effectively overcomes the known pharmacokinetic interaction with EFV- based ART. LNG pharmacokinetic results from the participants enrolled in this dose escalation study (n=28) will be compared to HIV-infected Ugandan women on standard dose LNG without concomitant EFV-based ART.
Age
18 - 45 years
Sex
FEMALE
Healthy Volunteers
No
Infectious Diseases Institute
Kampala, Uganda
Start Date
April 6, 2017
Primary Completion Date
December 5, 2019
Completion Date
March 30, 2020
Last Updated
October 3, 2024
28
ACTUAL participants
Levonorgestrel
DRUG
Efavirenz
DRUG
Lead Sponsor
University of Nebraska
Collaborators
NCT04929028
NCT07071623
Data Source & Attribution
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