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Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant — DRIVE-1  

HIV Clinical Trial

Official title:
A Pharmacokinetic Evaluation of Etonogestrel Implant in HIV-infected Women on Darunavir Versus Ripilvirine-based Antiretroviral Therapy

Clinical Trial Summary

This study will evaluate the pharmacokinetic properties of rilpivirine and darunavir when used in combination with etonogestrel

Clinical Trial Description

Despite the benefits of hormonal contraceptives, significant drug-drug interactions (DDIs) with some antiretroviral therapies (ART) represent a barrier to effective family planning methods for HIV-infected women. It is therefore critical to generate data on the combined use of hormonal contraceptives and ART. This study is a prospective, non-randomized, open-label, parallel, two-group, sparse-sampling pharmacokinetic study to describe etonogestrel (ENG) pharmacokinetic (PK) parameters in two treatment groups (rilpivirine or darunavir- based ART) in 60 HIV-1 infected women. The primary endpoint is the comparison of the mean ENG concentrations at month 6 between the rilpivirine or darunavir treatment groups versus historical controls. This study will provide information on effective ART options for HIV positive women who opt for the contraceptive implant as a family planning method of choice. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03589040
Study type Interventional
Source Makerere University
Contact Senior research administrator
Phone 0392878652
Email sokoboi@idi.co.ug
Status Recruiting
Phase Phase 2
Start date September 25, 2018
Completion date June 2020
View Details
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