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Symtuza for Rapid Reinitiation of ART in HIV-1
NCT04388904Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2021
- Primary completion
- Apr 2024
- Countries
- 1
- Sponsor
- Crofoot Research Center
- Modality
- Small Molecules
- Conditions
- human immunodeficiency virus type 1 infection (HIV-1)
01
Overview
Phase 4, open-label, single-arm trial of tenofovir alafenamide in human immunodeficiency virus type 1 infection (HIV-1), sponsored by Crofoot Research Center. Primary endpoint: The proportion of subjects who have HIV-1 RNA <50 copies/mL at week 48. Started Sep 2021; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Symtuza
Single-arm receiving Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC) once daily
03
Who it enrols
HIV-1 infected adults who are treatment-experienced but have been off ART for at least 12 weeks, with no known resistance to the study drug components (except M184V alone which is permitted).
04
Endpoints
Primary
The proportion of subjects who have HIV-1 RNA <50 copies/mL at week 48
Secondary
Proportion of subjects who have HIV-1 RNA <200 copies/mL at week 24
Change from baseline in HIV-1 RNA viral load
Change in baseline CD4 cell count
Discontinuation due to adverse events
Proportion of subjects experiencing grade 3 and 4 adverse events
Proportion of subjects experiencing serious adverse events
Proportion of subjects experiencing grade 3 and 4 laboratory abnormalities
Proportion of subjects meeting resistance stopping rules requiring discontinuation
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