HIV-1-infection
Conditions
Keywords
HIV, QOL, Elderly
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.
Interventions
DRUGB/F/TAF
50/200/25 mg fixed-dose combination administered orally once daily without regard to food.
Sponsors
Gilead Sciences
Tulika Singh, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
Countries
United States
Contacts
Primary ContactGreg Jackson, BS, MBA
Outcome results
None listed