Study to Assess Switching to B/F/TAF in Treatment Experienced People With HIV Who Are at Least 65 Years of Age

Tulika Singh, MD

Status and phase: Unknown; Phase 4

Conditions: HIV-1-infection

Treatments: Drug: B/F/TAF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05147740

CO-US-38-5713

Details and patient eligibility

About

To assess patient reported treatment satisfaction and medication tolerability in virologically suppressed HIV-1 infected adults who are at least 65 years of age who switch to a bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination regimen.

Enrollment: 50 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Be at least 65 years of age at the time of signing the informed consent form.
2. Be currently receiving an antiretroviral regimen for ≥ 3 months prior to the screening visit.
3. Have documented plasma HIV-1 RNA < 50 copies/mL for a minimum of 3 months on current ART regimen.
4. Have a plasma HIV-1 RNA < 50 copies/mL at screening visit.

Key Exclusion Criteria:

1. Have resistance to tenofovir (K65R/E/N, ≥3 thymidine analogue mutations or T69-insertions), primary INSTI-resistance, or a history of failure on an INSTI-based regimen.
2. Have been treated with B/F/TAF
3. Participants with CrCl <30 mL/min
4. Known or suspected severe hepatic impairment (Child-Pugh Class C)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

B/F/TAF

Experimental group

Description:

B/F/TAF for 48 weeks

Treatment:

Drug: B/F/TAF