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

HIV-1-infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05147740
• Other study ID #: CO-US-38-5713
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2021
• Est. completion date: December 2022

Study information

• Verified date: December 2021
• Source: Desert AIDS Project
• Contact: Greg Jackson, BS, MBA
• Phone: 760-992-0445
• Email: gjackson[@]daphealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Drug:
• B/F/TAF
50/200/25 mg fixed-dose combination administered orally once daily without regard to food.

Locations

Country	Name	City	State
United States	DAP Health	Palm Springs	California

Sponsors (2)

Lead Sponsor	Collaborator
Tulika Singh, MD	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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