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
Name: Doravirine/Lamivudine/Tenofovir
Description: The proportion of participants with undetectable plasma HIV-1 RNA levels at Week 24 will be recorded.
Measure: Proportion of participants with undetectable plasma HIV-1 RNA levels (<50 copies/mL) at week 24 Time: 24 weeksDescription: Evaluation of viral suppression by recording the proportion of patients with undetectable plasma HIV-1 RNA levels (<50 copies/mL) at weeks 4, 12 and 48
Measure: Proportion of patients with undetectable plasma HIV-1 RNA levels (<50 copies/mL) at weeks 4, 12 and 48 Time: At week 4, 12, 48Description: Evaluation of changes in CD4 count from baseline recorded at weeks 24 and 48.
Measure: Change from baseline in plasma CD4 levels at weeks 24 and 48 Time: At week 24, 48Description: Evaluation of the number of antiretroviral resistance mutations that emerge in participants with virological failure
Measure: Emergence of antiretroviral resistance mutations in participants with virological failure Time: 48 weeksAllocation: N/A
Single Group Assignment
There are 3 SNPs
K103N, Y181C, etc as listed in the protocol) - CD4 > 200 cells/uL - Creatinine clearance > 50 mL/min - Body mass ≥ 35 kg. --- K103N ---
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. --- K65R ---
K103N, Y181C, etc as listed in the protocol) - CD4 > 200 cells/uL - Creatinine clearance > 50 mL/min - Body mass ≥ 35 kg. --- K103N --- --- Y181C ---