NCT02722421

Pharmacologic Strategies to Use the Levonorgestrel Implant in HIV-infected Women

A Pharmacokinetic Evaluation of Increased Dose Levonorgestrel Implant and Efavirenz-Based Antiretroviral Therapy In HIV-Infected Ugandan Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HIV
• Contraception

Interventions

Type	Name	Description
DRUG	Levonorgestrel	Increased dose levonorgestrel implant plus efavirenz-based antiretroviral therapy.
DRUG	Efavirenz	Participants will receive efavirenz-based ART as part of standard of care

Timeline

• Start date: 2017-04-06
• Primary completion: 2019-12-05
• Completion: 2020-03-30
• First posted: 2016-03-30
• Last updated: 2024-10-03

Locations

1 site across 1 country: Uganda