Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine
Status:
Active, not recruiting
Trial end date:
2021-04-21
Target enrollment:
Participant gender:
Summary
The current study proposal is an open label observational trial for maintenance of virologic
suppression, and is designed as a non- inferiority switch trial. The study will involve
approximately 30 patients, which includes a PK arm of approximately 10 patients. The study
will also include secondary outcomes of quality of life (QOL) and weight changes
Hypothesis:
Patients with prior NUC or NNRTI resistance (but not to rilpivirine or doravirine) will
maintain their virologic suppression after a drug regimen switch from
rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to
bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine. The switch
therapy will avoid food interactions, and will be well tolerated by subjects.