About The Study
To evaluate the safety, tolerability and efficacy of four doses of posaconazole (SCH 56592), compared to fluconazole in the treatment of oropharyngeal candidiasis, or thrush, in HIV-positive patients. Ultimately, the study evaluated whether posaconazole can be a therapeutic option for thrush.
Study Approach
This was a multicentre phase II, randomized, double-blind, parallel-group, active control comparative study. HIV-positive participants with a fungal infection in the mouth or/and throat were randomized to receive either 50, 100, 200 or 400 mg of posaconazole, or fluconazole 100 mg daily for 14 days. The study was designed to compare the clinical success between the groups, defined as the absence of lesions and symptoms or minimal symptoms on day 14. The study also looked at the fungal response based on quantitative fungal culture measurements.
Study population
A total of 469 participants between 19 and 65 years of age received at least one dose of study medication, 83 female, 386 male. Demographics were similar across all treatment groups. The median CD4 cell count/mm3 were 55, 68, 82 and 82 for the posaconazole doses of 50 mg, 100 mg, 200 mg and 400 mg respectively. The median CD4 count for the fluconazole treatment group was 54.
Results
Four hundred and eighty-five participants were randomized. The data analysis was performed on the 437 participants who received at least one dose of study medication and had a positive culture for thrush at visit 1. Clinical success, as defined above, was achieved in 85%, 87%, 77% and 87% respectively in the 50, 100, 200 and 400 mg posaconazole groups versus 89% success rate in the fluconazole group. This was statistically equivalent. The fungal infection was eradicated (based on fungal culture measurements as per study definition) in 36%, 37%, 35% and 40% respectively in the posaconazole groups versus 50% in the fluconazole group. This was not statistically equivalent. Except for nausea (17% in the fluconazole group versus 5-9% in the posaconazole group) adverse events were few, mild and similar in all groups.
Conclusions
Oral therapy of thrush with posaconazole is as effective clinically as fluconazole in HIV-positive patients. In addition, both drugs were well tolerated with few adverse events. Posaconazole appears to be an effective alternative for thrush in HIV-positive patients.
Note: These results were taken from an abstract presented at the 40th ICAAC, Toronto, 2000.