SNPMiner Trials (Home Page)
Report for Mutation T66A
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
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)
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