Byramjee Jeejeebhoy Medical College (BJMC) Clinical Research
Jai Prakash Narayan Road
Office of the Dean
Pune, Maharashtra. 411001
A5384: A Phase II, Randomized, Open-Label Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents with Tuberculous Meningitis: Improved Management with Antimicrobial AGents Isoniazid rifampiciN LinEzolid for TBM (IMAGINE-TBM)
A5384 is a trial for people who have or might have tuberculous meningitis (TBM). TBM is an infectious disease that causes inflammation of the membranes that surround the brain and the spinal cord (meninges). TBM is caused by the bacterium Mycobacterium tuberculosis, which can be found elsewhere in the body, usually the lungs, but can travel via the bloodstream to the meninges, where the bacteria cause TBM.
This trial will compare a new experimental regimen of anti-TBM medicines taken over a 6-month time period with the current standard of care regimen of anti-TBM medicines taken over a 9-month time period.
HIV (and comorbidities)
A5332: REPRIEVE Trial
In this study, people between the ages of 40 and 75 with HIV will be randomized (like flipping a coin) to take the pill pitavastatin OR a placebo (non-active pill) to see if pitavastatin can help prevent heart disease and death in people who are taking HIV medication. You will not know if you are taking pitavastatin or placebo. The REPRIEVE trial will enroll about 7500 people from several countries.
A5300B/I2003B:Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Participants (PHOENIx)
This trial is in household contacts (HHC) at high risk for developing multidrug resistant tuberculosis (MDR-TB) which is an infection that does not get better with standard treatment for TB. HHC means any person that lives with, has lived with, or shared housekeeping duties in a home or the same place with a person (an Index Case) who has pulmonary MDR-TB (a lung infection or pneumonia with TB) and started treatment for MDR-TB within the past 90 days. It is also for people who have spent more than 4 hours indoors with the index case, during the week before they started MDR-TB treatment.
High-risk household contacts are those with HIV or an immune system problem not from HIV like cancer , latent TB infection (a history of TB infection in the past based on testing), and young children below the age of 5 years.