Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Switch to E/C/FTC/TAF daily · 1 trial · 4 indications
Change in mitochondrial function \[abnormal mitochondrial dynamics \[(cellular oxygen consumption (COC)\] over 12 months after switch of antiretrovirals.
| Arm | Type | Description |
|---|---|---|
| Switch to E/C/FTC/TAF daily | EXPERIMENTAL | Intervention: Participants will be asked to switch antiretrovirals (ART) for a period up to 12 months and mitochondrial physiology will be assessed using a variety of assays. The new ART will be 1. If the participant is on an ART other than Elvitegravir (ELV)/cobicistat CO)/emtricitabine (FTC)/tenofovir (TDF)\] (E/C/FTC/TDF) then the participant will be asked to switch to E/C/FTC/TDF for up to 6 months. This will allow for future switch (after these 6 months) from E/C/FTC/TDF 1 tablet once daily to E/C/FTC/ tenofovir alafenamide (TAF) 1 tablet once daily for a period of 12 months. 2. If the participant is on E/C/FTC/TDF 1 tablet once daily then the participant will be asked to switch from /C/FTC/TDF 1 tablet once daily to /C/FTC/TAF 1 tablet once daily for a period of 12 months. |
| Name | Type | Description |
|---|---|---|
| Switch to E/C/FTC/TAF daily | DRUG | If the participant is on an antiretroviral regimen other than Elvitegravir (ELV)/cobicistat CO)/emtricitabine (FTC)/tenofovir (TDF)\] (E/C/FTC/TDF) then the participant will be asked to switch to E/C/FTC/TDF for up to 6 months. This will allow for future switch (after these 6 months) from E/C/FTC/TDF 1 tablet once daily to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/FTC/TAF) 1 tablet once daily for a period of 12 months. b) If the participant is on E/C/FTC/TDF 1 tablet once daily then the participant will be asked to switch from /C/FTC/TDF 1 tablet once daily to /C/FTC/TAF 1 tablet once daily for a period of 12 months. |
Inclusion Criteria: * Inclusion criteria for HIV negative participants All HIV negative participants must meet the following criteria: 1. 18 years of age or older 2. Understands and agrees to local STI reporting requirements 3. HIV negative at screening by self-report, with no significant medical...