NCT03589040

Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Makerere University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• HIV
• Contraception

Interventions

Type	Name	Description
DRUG	Etonogestrel 68Mg Implant	Etonogestrel single-rod subdermal implant (68mg/rod) will be administered to all study participants
DRUG	rilpivirine	Oral rilpvirine 25mg
DRUG	darunavir	Oral darunavir+ritonavir 600/100mg

Timeline

• Start date: 2018-09-25
• Primary completion: 2019-06-01
• Completion: 2020-06-01
• First posted: 2018-07-17
• Last updated: 2019-03-28

Locations

1 site across 1 country: Uganda