SNPMiner Trials by Shray Alag

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Report for Mutation G163E

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials

1 Darunavir/Cobicistat and Dolutegravir to Maintain Virologic Suppression and Reduce NRTI-associated Toxicity (The 'deNUC' Study; TMC114HIV2030)

This is a clinical research study to see if switching to Darunavir/Cobicistat ((PREZCOBIX™, DRV/COBI ) and Dolutegrivir (Tivicay®, DTG) in HIV-infected individuals with undetectable HIV viral load on nucleos(t)ide reverse transcriptase inhibitor (NRTI)-containing therapy will be effective in maintaining virologic suppression at 48 weeks of treatment.

NCT02499978 HIV/AIDS Drug: Darunavir/Cobicistat Drug: Dolutegravir
MeSH:Acquired Immunodeficiency Syndrome HIV Infections

Prohibited protease mutations: V11I, V32I, L33F, I47V/A/L, I50V, I54T/S/L/M, T74P, L76V, V82F, I84V, or L89V Prohibited INSTI mutations: E92Q, E92K/A, G140S/A/C, Q148H/R/K or Q148 substitution plus any of the following: L74I/M, E138A/D/K/T, G140A/S, Y143H/R, E157Q, G163E/K/Q/R/S, or G193E/R. --- V11I --- --- V32I --- --- L33F --- --- I47V --- --- I50V --- --- I54T --- --- T74P --- --- L76V --- --- V82F --- --- I84V --- --- L89V --- --- E92Q --- --- E92K --- --- G140S --- --- Q148H --- --- L74I --- --- E138A --- --- G140A --- --- Y143H --- --- E157Q --- --- G163E ---

Primary Outcomes

Description: Compare between arms the proportion of patients maintaining virologic suppression (i.e., no confirmed HIV RNA levels ≥200 copies/mL) at Week 24

Measure: Virologic suppression (24 weeks)

Time: 24 weeks

Secondary Outcomes

Description: Evaluate the proportion of participants who maintain virologic suppression 24 weeks post-switch (i.e. at 24 weeks in the immediate switch arm and at 48 weeks in the delayed switch arm)

Measure: Virologic Suppression (48 weeks)

Time: 48 weeks

HPO Nodes