Cryptococcosis Clinical Trial
Official title:
Cryptococcal Antigen Screening Plus Sertraline
Cryptococcal meningitis or "Crypto" is a life threatening fungal infection around the brain
that requires hospitalization for treatment for 14 days and then continued therapy. Crypto
causes 15-20% of HIV/AIDS-related deaths worldwide. However, this infection can be detected
before one develops symptoms and becomes ill. People can be screened for infection by a blood
test to detect "cryptococcal antigen," (called CrAg), which is part of the fungus, in blood.
The World Health Organization and over 22 countries worldwide recommend CrAg screening of all
persons with advanced AIDS entering or re-entering into HIV care.
However, it is not known how best to treat people with cryptococcal antigen in their blood,
who don't otherwise yet have symptoms of infection around their brain. If no treatment is
given, almost all people will develop infection of the brain and/or die. International
guidelines suggest using both HIV medicines and an anti-fungal medicine, called fluconazole,
to treat this early infection. However, despite this treatment approximately 1 in 4 people
may get sick and/or die.
Researchers have recently discovered another medicine that may work against the Cryptococcus
fungus. This medicine is called Sertraline, and it is actually a medicine that has been used
for more than 25 years to treat depression (sadness). Sertraline is one of the most commonly
used medicines worldwide.
The purpose of this research clinical trial is to determine if standard fluconazole
antifungal therapy plus a high dose of Sertraline, will be better than standard fluconazole
therapy alone for treating early disseminated cryptococcal infection in persons who are
asymptomatic and do not yet have infection of the brain (i.e. meningitis).
This study seeks to test if Sertraline will improve survival through 6-months. Prior studies
have shown that >90% of those who survive 6-months will survive >5 years.
This is a double-blind, randomized placebo-controlled clinical trial testing sertraline as an antifungal medicine in combination with fluconazole for treatment of HIV-infected persons with AIDS and asymptomatic cryptococcal antigenemia (CrAg+). ;
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