This study will evaluate the pharmacokinetic properties of rilpivirine and darunavir when used in combination with etonogestrel
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Etonogestrel single-rod subdermal implant (68mg/rod) will be administered to all study participants
Oral rilpvirine 25mg
Oral darunavir+ritonavir 600/100mg
Infectious Diseases Institue
Kampala, Uganda
RECRUITINGConcentration of etonogestrel
Comparison of the mean etonogestrel concentrations at month 6 between rilpivirine and darunavir treatment groups versus historical controls.
Time frame: Six months of combined use.
Concentration of rilpivirine and darunavir
Rilpivirine and darunavir mean concentration changes prior to implant placement and then over the duration of the study time period.
Time frame: 12 months
Number and severity of adverse events
Any signs and symptoms related to hormone exposure, including abnormal vaginal bleeding and local or systemic adverse events observed during the study period in both study groups.
Time frame: 12 months
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