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

Tulika Singh, MD50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV-1-infection

Interventions

B/F/TAFDRUG

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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

DAP Health

Palm Springs, California, United States

RECRUITING

Outcomes

Primary Outcomes

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.

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.

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.

Time frame: 48 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Central Contacts

Greg Jackson, BS, MBA

CONTACT

760-992-0445 gjackson@daphealth.org

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.