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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tulika Singh, MD
• Collaborator: Gilead Sciences

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)