Evaluation of Pharmacokinetic Drug-drug Interactions Between Hormonal Contraceptives and Doravirine-containing ART Among Women Living With HIV in South Africa

Prior treatment

• Currently on 2nd line, 3rd line, or salvage ART regimens,
• 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,

Other illness

• 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,
• We will test for hepatitis B and if participant has the infection, they will be excluded from the study. We also will test for hepatitis B immunity and the participant is not immune, we will offer the vaccination against hepatitis B infection.
• 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.

Lab values

• 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

Other

• Currently pregnant or intending to become pregnant within the next 6 months,
• Currently breastfeeding or intending to breastfeed within the next 6 months,
• Currently obese (BMI≥30),
• 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

• 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:
  • 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.