Evaluation of Pharmacokinetic Drug-drug Interactions Between Hormonal Contraceptives and Doravirine-containing ART Among Women Living With HIV in South Africa (EPIC)
HIV Infections, Contraception, Drug-drug Interaction
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility Criteria
Inclusion Criteria:
- HIV-positive
- Currently on 1st line ART (namely EFV- or DTG-containing ART),
- Have documented or confirmed viral suppression for HIV (defined as <40 copies/mL) within 3 months prior to study screening and after the start of the current ART regimen,
Contraception use:
a) Not currently on reliable contraception and intending to or willing to initiate use of study hormonal/non-hormonal contraceptive methods 6 weeks after DOR lead in period (and willing to continue use for subsequent 12 to 24 weeks),
- Able and willing to comply with all study procedural requirements, Able and willing to provide informed consent for study participation in either English or Zulu,
- Able and willing to provide adequate locator information, as defined in site SOPs,
- Negative pregnancy test at Screening and Enrollment, and
- At Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, vaginal products, or vaccines for the duration of study participation.
Exclusion Criteria:
- Currently on 2nd line, 3rd line, or salvage ART regimens,
- Currently pregnant or intending to become pregnant within the next 6 months,
- Currently breastfeeding or intending to breastfeed within the next 6 months,
- Use or anticipated use of drugs for the duration of the study period known to interact with hormonal implants, DMPA/MPA, or the respective ART regimen
- Current or planned concomitant use of other hormonal contraceptives,
- Currently obese (BMI≥30),
Has any of the following laboratory abnormalities at Screening Visit:
- Haemoglobin abnormality Grade 2 or higher
- Calculated creatinine clearance less than 50 mL/min by the Schwartz Equation,
Per participant report at Screening and Enrollment, intends to do any of the following during her study participation period:
- Relocate away from the study site
- Travel away from the study site for a time period that would interfere with product resupply and study participation,
Per participant report and/or clinical evidence of any of the following:
- Known adverse reaction to any of the study products (ever),
- Participation in any other research study involving drugs, medical devices or vaccines within 60 days of enrollment,
- At Enrollment, as determined by the PI/designee, has any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder, metabolic bone disease or infectious disease,
- Has any other condition that, in the opinion of the PI/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Sites / Locations
- Wits Reproductive Health and HIV Institute, Research Centre Clinical Research SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Active Comparator
Group 1 DOR + ETG
Group 2 DOR + IM DMPA
Group 3 DOR + SC MPA
Group 4 DOR + IUD
Group 5 DTG + DMPA
100mg DOR-containing ART [oral tablet taken daily] + 68mg ETG implant (follow up for 30 weeks)
100mg DOR-containing ART [oral tablet taken daily] + 150mg IM DMPA (follow up for 18 weeks)
100mg DOR-containing ART [oral tablet taken daily] + 104mg SC MPA (follow up for 18 weeks)
100mg DOR-containing ART [oral tablet taken daily] + 1 non-hormonal IUD device (follow up for 30 weeks)
50mg DTG-containing ART [oral tablet taken daily] + 150mg IM DMPA DMPA administered at enrolment (follow up for 18 weeks)