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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B/F/TAF | Experimental | B/F/TAF for 48 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B/F/TAF | Drug | 50/200/25 mg fixed-dose combination administered orally once daily without regard to food. |
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| 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 |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Greg Jackson, BS, MBA | Contact | 760-992-0445 | gjackson@daphealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Tulika Singh, MD | Dap Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DAP Health | Recruiting | Palm Springs | California | 92262 | United States |
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| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
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| 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 |