This study will evaluate the pharmacokinetic properties of Rilpivirine and Darunavir when used in combination with Levonorgestrel
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Levonorgestrel (75 mg/rod), 2 rods (150 mg) inserted subdermally
Oral ripilvirine 25mg once daily
Oral DRV/r 600/100mg twice daily
Infectious Diseases Institue
Kampala, Uganda
RECRUITINGLevonorgestrel concentrations: Change in mean levonorgestrel (LNG) concentrations
Comparison of the mean levonorgestrel (LNG) concentrations at month 6 between the rilpivirine (RPV) or darunavir (DRV) treatment groups versus historical controls
Time frame: 6 months
Change in mean rilpivirine concentration
Rilpivirine mean concentration change prior to implant placement and then over the duration of the study time period.
Time frame: 12 months
Change in mean darunavir concentration
Darunavir mean concentration change prior to implant placement and then over the duration of the study time period.
Time frame: 12 months
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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