The purpose of this study is to demonstrate the effectiveness of Symtuza® in a rapid reinitiation model of care in patients with HIV-1 infection and who are treatment-experienced but have been off of antiretroviral therapy (ART) for 12 or more weeks.
Name: Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC)
Description: The proportion of subjects who have HIV-1 RNA <50 copies/mL at week 48 as defined by the FDA snapshot analysis (ITT)
Measure: The proportion of subjects who have HIV-1 RNA <50 copies/mL at week 48 Time: 48 weekDescription: Proportion of subjects who have HIV-1 RNA <200 copies/mL at week 48 as defined by the per-protocol (PP) analysis set
Measure: Proportion of subjects who have HIV-1 RNA <50 copies/mL at week 48 Time: Week 48Description: Proportion of subjects who have HIV-1 RNA <200 copies/mL at week 48 as defined by the FDA snapshot analysis (ITT)
Measure: Proportion of subjects who have HIV-1 RNA <50 copies/mL at week 48 Time: Week 48Description: Proportion of subjects who have HIV-1 RNA <200 copies/mL at week 24 as defined by the FDA snapshot analysis (ITT)
Measure: Proportion of subjects who have HIV-1 RNA <200 copies/mL at week 24 Time: Week 24Description: Change from baseline in log10 HIV-1 RNA viral load at Weeks 24 and 48
Measure: Change from baseline in HIV-1 RNA viral load Time: Weeks 24 and 48Description: Change in baseline CD4 cell count at Weeks 12, 24, and 48
Measure: Change in baseline CD4 cell count Time: Weeks 12, 24, and 48Description: Proportion of subjects that required discontinuation after enrollment based on study stopping rules
Measure: Discontinuation after enrollment based on study stopping rules Time: Week 48Description: Proportion of subjects discontinuing therapy due to adverse events
Measure: Discontinuation due to adverse events Time: Week 48Description: Proportion of subjects experiencing grade 3 and 4 adverse events
Measure: Proportion of subjects experiencing grade 3 and 4 adverse events Time: Week 48Description: Proportion of subjects experiencing serious adverse events
Measure: Proportion of subjects experiencing serious adverse events Time: Week 48Description: Proportion of subjects experiencing grade 3 and 4 laboratory abnormalities
Measure: Proportion of subjects experiencing grade 3 and 4 laboratory abnormalities Time: Week 48Description: Proportion of subjects meeting resistance stopping rules requiring discontinuation of study drugs due baseline resistance findings
Measure: Proportion of subjects meeting resistance stopping rules requiring discontinuation of study drugs due baseline resistance findings Time: Week 48Description: Proportion of subjects with baseline RT, INI, and PR (primary and secondary) RAMs
Measure: Proportion of subjects with baseline RT, INI, and PR (primary and secondary) RAMs Time: Week 48Description: Proportion of subjects developing RAMs and loss of phenotypic susceptibility, when available, upon meeting PDVF
Measure: Proportion of subjects developing RAMs and loss of phenotypic susceptibility, when available, upon meeting PDVF Time: Week 48Description: Proportion of subjects with PDVF at Week 24 and Week 48
Measure: Proportion of subjects with PDVF at Week 24 and Week 48 Time: Weeks 24 and 48Description: Proportion of subjects lost to follow-up throughout the 48 Weeks of treatment
Measure: Proportion of subjects lost to follow-up throughout the 48 Weeks of treatment Time: Week 48Description: Proportion of subjects taking study drug at Week 48 who have a documented clinic visit with a healthcare provider within 90 days of Week 48 visit.
Measure: Proportion of subjects taking study drug at Week 48 who have a documented clinic visit with a healthcare provider within 90 days of Week 48 visit. Time: Week 48Description: Mean total satisfaction scores on the HIVTSQs at Weeks 4, 24, and 48
Measure: Mean total satisfaction scores on the HIVTSQs at Weeks 4, 24, and 48 Time: Weeks 4, 24, and 48Description: Mean total depression scores on the PHQ-9 at baseline and Weeks 4, 24, and 48
Measure: Mean total depression scores on the PHQ-9 at baseline and Weeks 4, 24, and 48 Time: Weeks 4, 24, and 48Description: Adherence as measured by pill count at Weeks 4, 12, 24, and 48
Measure: Adherence as measured by pill count at Weeks 4, 12, 24, and 48 Time: Weeks 4, 12, 24, and 48Allocation: N/A
Single Group Assignment
There is one SNP
- Known resistance to any of the components of D/C/F/TAF; subjects with known or identified FTC resistance attributed to an M184V mutation alone will be permitted to remain in the study. --- M184V ---