NCT03589027

Darunavir and Rilpivirine Interactions With Levonorgestrel Implant

A Pharmacokinetic Evaluation of Levonorgestrel Implant in HIV-Infected Women on Darunavir Versus Rilpivirine-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 Levonorgestrel

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 (PK) study to describe levonorgestrel (LNG) 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 LNG 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-1-infection
• Contraception

Interventions

Type	Name	Description
DRUG	Levonorgestrel two rod sub-dermal implant	Levonorgestrel (75 mg/rod), 2 rods (150 mg) inserted subdermally
DRUG	Rilpivirine	Oral ripilvirine 25mg once daily
DRUG	Darunavir+Ritonavir	Oral DRV/r 600/100mg twice daily

Timeline

• Start date: 2018-08-07
• 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