Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorChelsea and Westminster NHS Foundation Trust

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Doravirine
  • Dolutegravir
  • Triple cART regimen

Treatment groups

150 Participants
are divided into 2 treatment groups