PubMed · 7747646
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J J Ellner. 1995. Multidrug-resistant tuberculosis.. https://pubmed.ncbi.nlm.nih.gov/7747646/
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This randomized comparative study assessed the efficacy and safety of a 10-mg once-daily topical regimen of miconazole nitrate mucoadhesive buccal tablet (n = 178) versus a 400-mg once-daily systemic regimen of ketoconazole (n = 179) in HIV-positive patients with oropharyngeal candidiasis. A total of 357 patients were treated for 7 or 14 days depending on response after 7 days of treatment. Clinical response was the primary outcome variable, and secondary outcomes included microscopy, time to cure, symptom scores, and safety outcomes. A per-protocol analysis of 332 patients demonstrated that miconazole nitrate was not statistically significantly inferior to ketoconazole treatment. At day 7, the clinical response rate was 135 of 156 (87%) for miconazole nitrate and 137 of 153 (90%) for ketoconazole (90% confidence interval of the treatment difference: [-9%; 3%]). At the end of treatment, dysphagia was 1% in both groups. Microscopic findings paralleled the clinical results. The mucoadhesive tablet was generally well tolerated. A higher incidence of gastrointestinal disorders and drug-related adverse events was seen during ketoconazole treatment. The low-dose 10-mg miconazole mucoadhesive tablet is not inferior to systemic antifungal treatment with ketoconazole in the treatment of AIDS-related oropharyngeal candidiasis with and without dysphagia. It provides the first and only once-daily topical treatment option and should therefore be considered in first-line therapy for this condition, particularly in resource-poor settings, where ease of use can help to guarantee the success of therapy.
We conducted a retrospective, multicenter study evaluating the safety of discontinuing maintenance therapy for cryptococcal meningitis after immune reconstitution. Inclusion criteria were a previous definitive diagnosis of cryptococcal meningitis, a CD4 cell count of >100 cells/microL while receiving highly active antiretroviral therapy (HAART), and the subsequent discontinuation of maintenance therapy for cryptococcal meningitis. The primary end point was relapse of cryptococcal disease. As of July 2002, 100 patients were enrolled. When maintenance therapy was discontinued, the median CD4 cell count was 259 cells/microL and the median plasma virus load was <2.30 log10 copies/mL, and serum cryptococcal antigen was undetectable in 56 patients. During a median follow-up period of 28.4 months (range, 6.7-64.5; 262 person-years), 4 events were observed (incidence, 1.53 events per 100 person-years; 95% confidence interval, 0.42-3.92). Three of these patients had a CD4 cell count of >100 cells/microL and a positive serum cryptococcal antigen test result during the recurrent episode. In conclusion, discontinuation of maintenance therapy for cryptococcal meningitis is safe if the CD4 cell count increases to >100 cells/microL while receiving HAART. Recurrent cryptococcal infection should be suspected in patients whose serum cryptococcal antigen test results revert back to positive after discontinuation of maintenance therapy.