Status:
UNKNOWN
ADORE: Efficacy of DORavirine in Adults Living With HIV Experiencing Virological Failure on First-line Efavirenz-based Antiretroviral Therapy With NNRTI Resistance
Lead Sponsor:
Professor Francois Venter
Conditions:
HIV-1-infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed 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 adul...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04429152
Start Date
February 9 2021
End Date
September 1 2023
Last Update
June 7 2022
Active Locations (3)
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1
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, South Africa, 2196
2
Sunnyside Office Park
Johannesburg, Gauteng, South Africa
3
Wits RHI Yeoville Clinic
Johannesburg, Gauteng, South Africa