ADORE: Efficacy of DORavirine in Adults Living With HIV Experiencing Virological Failure on First-line Efavirenz-based Antiretroviral Therapy With NNRTI Resistance

Professor Francois Venter

Status and phase

Enrolling

Phase 3

Conditions

HIV-1-infection

Treatments

Drug: Doravirine/Lamivudine/Tenofovir

Study type

Interventional

Funder types

Other

Identifiers

NCT04429152

EZMiM018

Details and patient eligibility

About

This is a pilot study investigating the efficacy of Doravirine (DOR) in combination with Lamivudine (3TC) and Tenofovir Disoproxil Fumarate (TDF) administered over 48 weeks in adults living with HIV-1 experiencing virological failure on first-line Efavirenz-based antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor resistance

Full description

This is a single-arm, phase 3 pilot study investigating the efficacy of Doravirine (DOR) in combination with Lamivudine (3TC) and Tenofovir Disoproxil Fumarate (TDF) administered over 48 weeks in adults living with HIV-1 experiencing virological failure on first-line Efavirenz-based antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor resistance.

Approximately 25 male and female participants 18 years and older infected with HIV-1 and experiencing virological failure on efavirenz-based ART 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

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults living with HIV-1, 18 years and older
Viral load 5000 - 60 000 copies/mL on first-line efavirenz-based antiretroviral therapy
HIV genotype resistance test with first generation NNRTI resistance (e.g. K103N, Y181C, etc as listed in the protocol)
CD4 > 200 cells/uL
Creatinine clearance > 50 mL/min
Body mass ≥ 35 kg.

Exclusion criteria

Resistance to TDF on genotype (K65R)
"Significant resistance" to doravirine, denoted by a Stanford Score ≥ 15 on genotype
Virologic failure on any other regimen
Women who are pregnant at the time of the screening or enrolment visits
Active tuberculosis and/or are on anti-tuberculous 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.