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

NCT05147740 | Unknown Phase 4 FDA Drug

• 1 other identifier: CO-US-38-5713
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

HIV; QOL; Elderly

Outcome Measures

Primary Outcomes (2)

• Improvement in treatment satisfaction by a change in total satisfaction scale as measured by the HIVTSQ survey.

  Improvement in treatment satisfaction by a change in total satisfaction scale as measured by the HIVTSQ survey. The range of scores is between -33 and +33. The higher the score, the greater the improvement in satisfaction. Satisfaction may be positive or negative.

  48 weeks

• Improvement in overall quality of life as characterized by a change in total satisfaction scale as measured by the HIVDQoL survey.

  Improvement in overall quality of life as characterized by a change in total satisfaction scale as measured by the HIVDQoL survey. The range of scores is between -9 to +3. The higher the score the greater the impact. Impacts may be positive or negative.

  48 weeks

Secondary Outcomes (4)

• Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at W24

  Week 24

• Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at end of study

  Week 48

• Percentage of Participants experiencing Adverse Events (AEs) through End of Study (Week 48)

  Week 48

• Percentage of patients who reduced their number of total medications from baseline.

  Week 48

Study Arms (1)

B/F/TAF

EXPERIMENTAL

B/F/TAF for 48 weeks

Drug: B/F/TAF

Interventions

B/F/TAF DRUG

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

Also known as: Biktarvy®

B/F/TAF

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Have been treated with B/F/TAF
• Participants with CrCl \<30 mL/min
• Known or suspected severe hepatic impairment (Child-Pugh Class C)

Sponsors & Collaborators

• Tulika Singh, MD: lead
• Gilead Sciences: collaborator

Study Sites (1)

DAP Health

Palm Springs, California, 92262, United States

RECRUITING

MeSH Terms

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Study Officials

• Tulika Singh, MD

  Dap Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Greg Jackson, BS, MBA

CONTACT

760-992-0445; gjackson@daphealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Research and Associate Chief Medical Officer

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: December 7, 2021
• Study Start: July 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 7, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)