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

Phase 4

• Conditions: HIV-1-infection
• Interventions: Drug: B/F/TAF

• Registration Number: NCT05147740
• Lead Sponsor: Tulika Singh, MD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-08-24
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-06
• Last Update Submitted: 2021-12-06
• Study First Posted: 2021-12-07
• Last Update Posted: 2021-12-07
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
B/F/TAF	B/F/TAF	B/F/TAF for 48 weeks

Primary Outcome Measures

Name	Time	Method
Improvement in treatment satisfaction by a change in total satisfaction scale as measured by the HIVTSQ survey.	48 weeks	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.
Improvement in overall quality of life as characterized by a change in total satisfaction scale as measured by the HIVDQoL survey.	48 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at end of study	Week 48	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.
Percentage of Participants experiencing Adverse Events (AEs) through End of Study (Week 48)	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.
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 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.
Percentage of patients who reduced their number of total medications from baseline.	Week 48	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.

Trial Locations

Locations (1)

DAP Health; 🇺🇸 Palm Springs, California, United States