Status:
COMPLETED
Evaluation of Pharmacokinetic Drug-drug Interactions Between Hormonal Contraceptives and Doravirine-containing ART Among Women Living With HIV in South Africa
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Wits Reproductive Health and HIV Institute
Conditions:
HIV Infections
Contraception
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
The study investigators are conducting an observational, parallel group pharmacokinetic (PK) study among women living with HIV (WLHIV) already on 1st line antiretroviral therapy (ART) and virally supp...
Detailed Description
While DOR-containing ART has been evaluated in two large clinical trials, only 16-17% of the study participants were women and only 6-10% of them were African. In an epidemic, where the gendered major...
Eligibility Criteria
Inclusion
- 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
- 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,
- 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.
Key Trial Info
Start Date :
November 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2024
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04669678
Start Date
November 17 2021
End Date
February 5 2024
Last Update
April 8 2025
Active Locations (1)
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1
Wits Reproductive Health and HIV Institute, Research Centre Clinical Research Site
Johannesburg, South Africa, 2001