SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT04388904

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 4, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed-dose Combination (FDC) Regimen in Antiretroviral Treatment-experienced Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects Not Currently Receiving Any Antiretroviral Therapy.

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.

NCT04388904 HIV-1-infection
MeSH:Infection

1 Interventions

Name: Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC)

Description: Participants will receive Symtuza®. An oral tablet containing Darunavir 800 mg /Cobicistat 150 mg /Emtricitabine 200 mg /Tenofovir Alafenamide 10 mg FDC, once daily within 24 hours of the screening/ baseline visit.
Type: Drug
Group Labels: 1

Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC)


Primary Outcomes

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 week

Secondary Outcomes

Description: 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 48

Description: 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 48

Description: 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 24

Description: 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 48

Description: Change in baseline CD4 cell count at Weeks 12, 24, and 48

Measure: Change in baseline CD4 cell count

Time: Weeks 12, 24, and 48

Description: Proportion of subjects that required discontinuation after enrollment based on study stopping rules

Measure: Discontinuation after enrollment based on study stopping rules

Time: Week 48

Description: Proportion of subjects discontinuing therapy due to adverse events

Measure: Discontinuation due to adverse events

Time: Week 48

Description: Proportion of subjects experiencing grade 3 and 4 adverse events

Measure: Proportion of subjects experiencing grade 3 and 4 adverse events

Time: Week 48

Description: Proportion of subjects experiencing serious adverse events

Measure: Proportion of subjects experiencing serious adverse events

Time: Week 48

Description: Proportion of subjects experiencing grade 3 and 4 laboratory abnormalities

Measure: Proportion of subjects experiencing grade 3 and 4 laboratory abnormalities

Time: Week 48

Description: 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 48

Description: 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 48

Description: 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 48

Description: 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 48

Description: 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 48

Description: 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 48

Description: 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 48

Description: 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 48

Description: 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 48

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 M184V

- 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 ---



HPO Nodes