SNPMiner Trials by Shray Alag

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Report for Mutation E157Q

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There are 2 clinical trials

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

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 ---

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

2 Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals

This study will evaluate the potential drug-drug interactions between dolutegravir (DTG) and steady state rifapentine (RPT) when RPT is given with isoniazid (INH) daily for 4 weeks (1HP) as part of treatment for latent TB infection (LTBI) in HIV-1 and LTBI co-infected individuals.

NCT04272242 HIV Infection LTBI Drug: Dolutegravir (DTG) Drug: Isoniazid (INH) Drug: Rifapentine (RPT) Drug: Antiretroviral Therapy (ART) Dietary Supplement: Pyridoxine (Vitamin B6)
MeSH:Infection HIV Infections

This includes the following INSTI mutations: Q148 substitutions, T66A, L74I/M, E138A/K/T, G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, G193E/R, or N155H. --- T66A --- --- L74I --- --- E138A --- --- G140S --- --- Y143R --- --- E157Q ---

Primary Outcomes

Measure: DTG PK Parameter Maximum Plasma Concentration (Cmax) by visit week and arm

Time: Measured at Days 0 and 28

Measure: DTG PK Parameter Area Under the Curve (AUC0-12 for BID & AUC0-24 for QD dosing) by visit week and arm

Time: Measured at Days 0 and 28

Measure: DTG PK Parameter Minimum Plasma Concentration (Cmin) by visit week and arm

Time: Measured at Days 0 and 28

Secondary Outcomes

Description: Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017

Measure: Proportion of participants with all adverse events meeting the reporting criteria in the study protocol during administration of DTG with 1HP, by arm

Time: Measured through Week 4

Measure: Proportion of participants who discontinue study or study drugs during DTG and 1HP dosing, by arm

Time: Measured through Week 4

Measure: Proportion of participants with HIV-1 RNA levels >50 copies/mL

Time: Measured at Days 28 and 42

HPO Nodes