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

Professor Francois Venter

Status and phase

Completed

Phase 3

Conditions

HIV-1-infection

Treatments

Drug: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate

Study type

Interventional

Funder types

Other

Identifiers

NCT04433780

EZMiM017

Details and patient eligibility

About

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.

Full description

This is a pilot, open label, single-arm, single centre, phase 3, switch study exploring the safety of 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. The metabolic and neuropsychiatric outcomes among women (and their infants) in a representative African female population of reproductive potential will be investigated.

Approximately 100 women aged between 18 and 49 years old will be administered a once-daily, fixed-dose combination of doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg (DOR/3TC/TDF). The study includes screening and baseline visits, 4 study visits from Week 4 to Week 36, and an end of study visit at Week 48.

Enrollment

133 patients

Sex

Female

Ages

18 to 49 years old

Volunteers

No Healthy Volunteers

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).