Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine

Quest Clinical Research

Status and phase: Completed; Phase 4

Conditions: HIV-1-infection

Treatments: Drug: Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04538040

BETD-001

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Biktarvy + Doravirine Switch

Experimental group

Description:

bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day

Treatment:

Drug: Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch