DORA: A Doravirine-based First-line Antiretroviral Therapy for Women of Reproductive Potential Living With HIV

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a pilot study investigating the safety of Doravirine (DOR) in combination with Lamivudine (3TC) and Tenofovir Disoproxil Fumarate (TDF) administered over 48 weeks in women of reproductive potential living with HIV-1 switched from Efavirenz or Dolutegravir-based antiretroviral therapy on metabolic and neuropsychiatric outcomes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Professor Francois Venter; Willem Daniel Francois Venter
• Treatments: Lamivudine; Tenofovir

Criteria

Inclusion Criteria:

• Females, aged 18-49 years and ≥ 40 kg

• On a first-line EFV or DTG-containing regimen for at least six months and not more than 3 years

• Plasma HIV-1 RNA < 50 copies/mL in last 60 days

• Calculated creatinine clearance (CrCl) > 50 mL/min (Cockcroft-Gault formula)

• Baseline weight measurement available at ART initiation.

Exclusion Criteria:

• Virological failure on any other regimen

• Women who are pregnant at the time of the screening or enrolment visits or have had a pregnancy gestation ≥ 28 weeks in the preceding 2 years

• Active tuberculosis and/or are on antituberculosis therapy at the time of the screening or enrolment visits

• Taking (and cannot discontinue) prohibited concomitant medications listed in protocol at least two weeks prior to the enrolment visit and for the duration of the study period (see potential drug interactions section for list).