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. 2020 Apr 28;2020(4):CD013594. doi: 10.1002/14651858.CD013594

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
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
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)