Recruiting

B/F/TAF

Sponsor:

Tulika Singh, MD

Code:

NCT05147740

Conditions

HIV-1-infection

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

B/F/TAF

Study Details

Brief 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.

Conditions

HIV-1-infection

Study ID

NCT05147740

Start date

Jul 1, 2021

Status verified date

Dec, 2021

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: B/F/TAF

B/F/TAF for 48 weeks

Interventions

B/F/TAF

50/200/25 mg fixed-dose combination administered orally once daily without regard to food.

Primary outcome measure

  • Improvement in treatment satisfaction by a change in total satisfaction scale as measured by the HIVTSQ survey. [ Time Frame: 48 weeks ]
  • Improvement in overall quality of life as characterized by a change in total satisfaction scale as measured by the HIVDQoL survey. [ Time Frame: 48 weeks ]

Central Contacts and Locations

Central contacts

Locations

DAP Health

Recruiting

Palm Springs, California, United States, 92262

Contacts

Principal Investigator:

Tulika Singh, MD

More Information

Sponsor

Tulika Singh, MD

Last update posted

Dec 7, 2021

Last verified

Dec, 2021

Keywords

  • HIV
  • QOL
  • Elderly

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tulika Singh, MD on 2021-12-07.