ACTG to initial clinical trial to assess new three-month TB treatment

AIDS Clinical Trials Group (ACTG), one of the largest global HIV clinical research companies, has announced the launch of a clinical trial called ‘A5362’, also referred to as CLO-FAST.

Credible sources state that the study will focus on evaluation of a three-month TB treatment. The treatment regimen will involve a high dose rifapentine coupled with clofazimine.

The clinical trial will primarily address people with drug-susceptible tuberculosis (TB). This study is recognized as the first TB regimen designed with preclinical evidence of effectiveness.

Additionally, it is also first treatment routine with a study period less than four months to be a part of a clinical trial.

A5362 will determine the potential efficacy of the drug candidate, clofazimine, in combination with other treatments that are previously known to be effective against TB.

It will comparatively place the early efficacy results of the clofazimine-rifapentine regimen alongside the six-month standard TB therapy regimen.

Furthermore, A5362 will determine whether the combination TB therapy is eligible for further assessment in a large phase 3 clinical trial. The clinical trial will examine 185 participants for a period of 65 weeks.

Clofazimine will be a crucial experimental candidate during the trial known for achieving high tissue concentrations. The drug is speculated for its ability to assist in maintaining a sustained antimicrobial activity post treatment.

According to preclinical studies, a combination of clofazimine with other TB therapies may showcase powerful synergies significantly shortening TB treatment.

Judith Currier, M.D., M.Sc., Vice Chair, ACTG, said that lowering the treatment duration for TB stands to be one of the most important goals of infectious disease research worldwide.

The A5362 trial aims to build upon those findings by offering ACTG a better understand about the activity of clofazimine and if it holds the potential to shorten TB treatment to three months.

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