ACTG174, 1994.
Study characteristics | ||
Methods | Single arm trial | |
Participants | 49 people with PDH according to the revised protocol | |
Interventions | Induction: FCN 1200 mg on first day, then 600 mg OD for 8 weeks Maintenance: FCN 200 mg OD for ≥ 1 year Following revision of protocol due to high failure rate (10/20) Induction: FCN 1600 mg on first day, then 800 mg OD for 12 weeks Maintenance: 400 mg OD for 1 year |
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Outcomes | "Treatment response" Induction: 36/49 (73.5%) participants responded at 12 weeks; 28 of these had resolution of signs/symptoms and negative cultures; 8 had clinical response but cultures missing/not done 7/49 failed treatment: 1 died histoplasmosis and pneumocystis around day 3 Maintenance: 11/36 participants relapsed. Median time on maintenance was 30 weeks. 10/11 had blood cultures, 8/10 were positive 1/36 participants withdrew due to drug toxicity |
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Age | Mean 36 (range not stated) years | |
Setting | USA | |
Disease severity | Mild to moderate | |
Notes | Study terminated early due to relatively high relapse rate (compared to earlier ITRA trial) |