SNPMiner Trials by Shray Alag

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Report for Mutation T66A

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials

1 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 ---

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