SNPMiner Trials (Home Page)
Report for Mutation T97A
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 Efficacy and Safety of a Simplification Strategy Based on Dolutegravir and Darunavir / Cobicistat vs Optimized Treatment in Suppressed HIV-1-infected Patients Carrying Archived Multidrug Resistance Mutations.
The availability of antiretroviral therapy has led to a reduction in morbidity and mortality in patients with chronic HIV infection. The treatment, however, is not free of side effects, has potential interactions with other medications, is expensive and can be complex, especially in those patients who are very experienced and with mutations that give them resistance to multiple drugs. For this reason, the development of simplification strategies that avoid unnecessary exposure to antiretroviral agents remains of great interest. This is a simplification study, in which the investigators try to evaluate that with less medication the investigator can maintain the same virological control of the disease. This would mean a lower burden of medication for patients, facilitating its administration and reducing the number of unwanted side effects. Specifically, the investigators intend to evaluate the treatment with Darunavir / cobicistat plus Dolutegravir as a simplification strategy, since both drugs are taken once a day, have a powerful antiviral activity, even against antiretroviral resistant viruses, and are among the best tolerated (with fewer side effects). The results reported in some observational studies suggest that two-drug therapy (bitherapy) as a simplification strategy could also be safe and effective, however, as far as the investigators know, there are no data and clinical trials that specifically evaluate darunavir / cobicistat plus dolutegravir as a strategy of simplification.
NCT03683524 HIV-1 Infection Drug: Dolutegravir (DTG) plus Darunavir/cobicistat (DRV/cobi). Drug: Current ART
T66I, 74M, E92Q, T97A, F121Y, E138A/K, G140A/S, Y143R/H/C, S147G, Q148H/K/R, N155H AND R263K) in historical genotyping tests. --- T66I --- --- E92Q --- --- T97A ---
Primary Outcomes
Description: HIV-1 RNA < 50 copies/mL using a Time to Loss of Virological Response (TLOVR).
Measure: Plasma HIV-1 RNA < 50 copies/mL at 48 weeks Time: week 48Secondary Outcomes
Description: Percentage of patients developing ART-associated adverse events leading to treatment discontinuation.
Measure: Percentage of patients developing ART-associated adverse events Time: Since baseline to week 48Description: CD4+ cell count changes
Measure: Changes in CD4+ cell count Time: Since baseline to week 48Description: Emergence of new mutations in HIV-1 protease and integrase assessed with a genotyping test (attempted on any post Day 1 sample with HIV-1 RNA ≥ 50 copies/mL).
Measure: Emergence of new mutations in HIV-1 protease and integrase Time: Baseline and in case of virological failure, defined as ≥ 50 copies/mL in 2 consecutive determinations or a single HIV-1 RNA values > 1000 copies/mL. We can observe a virological failure throughout the study (from baseline to week 48)Description: HIV-1 RNA< 50 copies/mL at 24 weeks by TLOVR
Measure: Plasma HIV-1 RNA < 50 copies/mL at 24 weeks Time: Week 24Description: HIV-1 RNA < 50 copies/mL at 24 and 48 weeks using the FDA snapshot analysis (sensitivity analysis).
Measure: Plasma HIV-1 RNA < 50 copies/mL at 24 and 48 weeks Time: Week 24 and 48Description: Description of plasmatic trough levels of DTG and DRV/cobi in the experimental group, and in those participants experiencing virological failure.
Measure: DTG and DRV/cobi plasma concentration Time: Week 4Description: ART prices
Measure: Cost associated with the antirretroviral treatment of the study Time: Since baseline to week 48Description: Prices of clinical controls during the study
Measure: Estimated costs of clinical controls Time: Since baseline to week 48Measure: Genotyping tests cost Time: At virological failure, defined as ≥ 50 copies/mL in 2 consecutive determinations or a single HIV-1 RNA values > 1000 copies/mL. We can observe a virological failure throughout the study (from baseline to week 48)