Combination antiretroviral therapy (cART) HIV treatments are associated with increased quality of life, and a normalisation of life expectancy in people living with HIV. However, long-term use of cART can lead to side-effects through exposure to drug-related toxicity.
For this reason researchers are interested in looking at alternative therapies that might expose patients to fewer and less severe side effects while providing the same quality of care as antiretroviral therapies most often used to treat HIV.
The purpose of this study is to investigate if the study drug combination that is being tested (doravirine + dolutegravir) is safe compared with other triple cART regimens.
HIV-1 infected, 18 years or older
On stable & suppressive triple cART for at least 6 months
No evidence of resistance to DOR or DTG
No laboratory abnormalities, medical/psychiatric conditions or alcohol/drug use considered a barrier to participation by investigators
History of virological failure on an NNRTI in absence of a post-failure genotypic resistance test proving absence of resistance to DOR
History of virological failure on an INSTI in absence of a post-failure genotypic resistance test proving absence of resistance to DTG (INSTI mutations that will lead to the need of administering DTG twice-daily are considered as resistance to DTG - and the subject will be considered NOT eligible)
Concomitant medication contra-indicated with DTG or DOR
Haemoglobin <9 g/dL
Parallel
Doravirine
DrugAntiretroviral, Non-nucleoside Reverse Transcriptase Inhibitor
Dolutegravir
DrugAntiretroviral, Integrase strand transfer inhibitors
Triple cART regimen
Other interventionParticipant standard triple cART regimen
Percentage of Participants with undetectable plasma HIV RNA levels at Week 48
Undetectable will be defined as plasma HIV RNA levels of \<50 copies/ml. Any patient with HIV RNA levels \>50 copies/ml at analysis time points will have a repeat test
Proportion of patients treated on each treatment arm with HIV viral load less than 50 copies/ml to determine absolute efficacy of study treatments
Proportion of patients treated on each treatment arm with HIV viral load less than 50 copies/ml at weeks and 24, 72 and 96.
Frequency and severity of adverse events to determine safety and tolerability of study treatments
Occurrence of adverse events (including laboratory results), severity of adverse events and occurrence of treatment discontinuations measured through adverse event reporting by sites.
Changes in CD4 count and CD4:CD8 ratio to determine safety and tolerability of study treatments
CD4 count and CD4:CD8 ratio will be measured at screening and compared to measurements in both arms weeks 24, 48, 72 and 96
Scores from participant-recorded outcome measures on quality of life to determine safety and tolerability of study treatments
Scores from participant-recorded outcome measures at weeks 0, 24, 48, 72 and 96: EuroQoL EQ-5D-3L Questionnaire Score from 0 to 100 (with 100 as best outcome)
Serum Neurofilament light chains (sNFL) comparison
NFL serum levels as measured at weeks 0, 48, 96.
Telomerase length comparison
Telomerase length measurements from samples taken at weeks 0, 48, 96.
Digit span tests comparison
Comparison of test results taken at weeks 0, 48, 96: • Digit span forward and backward nb - At Torino site only
Trail making tests comparison
Comparison of test results taken at weeks 0, 48, 96: • Trail making test A and B nb - At Torino site only
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