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

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

Summary

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

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

Details

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

Criteria

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.