A total of 494 participants was expected to enroll in the study but due to early study closure only 221 enrolled and participants are expected to be on the study for about 13 weeks. Evaluation of signs and symptoms of oral candidiasis was done by an evaluator who was blinded to the treatment assignment. Therapy was considered as failed if participants have no clinical improvement (assessed by severity of pseudomembranous candidiasis) during either treatment regimen. Male and female HIV-1 positive participants ≥ 18 years of age were randomized (as if by the toss of a coin) with equal probability and stratified by CD4+ T-cell counts and the use of antiretroviral therapy at the time of study entry to receive either topical GV solution (5 mL swish and gargle for 1 minute and spit two times daily) or nystatin oral suspension (5 mL swish for 1 minute and swallow four times daily) for 14 days.
#Swish and swallow nystatin trial
Why Should I Register and Submit Results?Ī5265 was a phase III, open-label (both the researchers and participants know which treatment was being administered) clinical trial to compare the safety and efficacy of topical GV to that of oral nystatin suspension.
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