Overview

Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine

Status:
Active, not recruiting
Trial end date:
2021-04-21
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Quest Clinical Research
Collaborator:
Gilead Sciences
Treatments:
Emtricitabine
Emtricitabine tenofovir alafenamide
Tenofovir
Criteria
Inclusion Criteria:

- HIV positive Males, age 45 or older

- Any genotypic or phenotypic resistance except k65R, 69 insertion, integrase
resistance, or resistance to rilpivarine or doravirine.

- Receiving combination antiretroviral regimen of rilpivirine/emtricitabine/tenofovir
alafenamide in combination with dolutegravir > 12 months and with viral load <50
copies/ mL on at least one occasion within the six months prior to switch.

- Suppressed viral load as defined by one plasma HIV RNA level < 50 copies/mL within
previous 6 months.

- Capable of providing informed consent

Exclusion Criteria:

- Any current or prior integrase inhibitor resistance

- Nucleoside reverse transcriptase (NRTI) mutation 69 insertion or k65R mutation

- Documented second generation non-nucleoside reverse transcriptase inhibitor (NNRTI)
resistance (rilpivirine or doravirine)