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

Switching to a Fixed Dose Combination of Biktarvy in Treatment Experienced People With HIV Who Are Currently Virologically Suppressed and at Least 65 Years of Age

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.

Study Overview

• Status: Recruiting
• Conditions: HIV-1-infection
• Intervention / Treatment: Drug: B/F/TAF

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Greg Jackson, BS, MBA; Phone Number: 760-992-0445; Email: gjackson@daphealth.org

Study Locations

• United States
  • California
    • Palm Springs, California, United States, 92262
      • Recruiting
      • DAP Health
      • Contact: Greg Jackson, BS, MBA; Phone Number: 760-992-0445; Email: gjackson@daphealth.org
      • Contact: Karina Ramirez; Phone Number: 760-656-8450; Email: kramirez@daphealth.org
      • Principal Investigator: Tulika Singh, MD
      • Sub-Investigator: Felipe Saavedra, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: B/F/TAF; B/F/TAF for 48 weeks	Drug: B/F/TAF; 50/200/25 mg fixed-dose combination administered orally once daily without regard to food.; Other Names: Biktarvy®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at W24	Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at W24 using FDA snapshot analysis, which defined a participant's virologic response status using only the viral load at the predefined timepoint within a certain window of time, along with study drug discontinuation.	Week 24
Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at end of study	Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at end of study (Week 48) using FDA snapshot analysis, which defined a participant's virologic response status using only the viral load at the predefined timepoint within a certain window of time, along with study drug discontinuation.	Week 48
Percentage of Participants experiencing Adverse Events (AEs) through End of Study (Week 48)	An Adverse Event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related . An AE can be any unfavorable and unintended sign, symptom, or disease associated with the use of a study intervention.	Week 48
Percentage of patients who reduced their number of total medications from baseline.	Percentage of patients who reduced their number of total medications from baseline. Polypharmacy is defined as 5 or more prescription medications and the Beers Criteria is utilized as a tool to evaluate potentially inappropriate prescriptions in this population.	Week 48

Collaborators and Investigators

• Sponsor: Tulika Singh, MD
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Tulika Singh, MD, DAP Health

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 24, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): December 7, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Elderly; HIV; QOL
• Other Study ID Numbers: CO-US-38-5713

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No