ACTG120, 1992.

Study characteristics
Methods	Single arm trial
Participants	59 people with PDH in induction phase 46 people in maintenance phase 96% male 65% white and non‐Hispanic people Diagnosis based on clinical findings and laboratory evidence, including stains of tissues or body fluids, positive cultures, or detection of Histoplasma capsulatum antigen in blood or urine. People receiving rifampicin therapy were excluded. Participants were allowed to receive amphotericin 1.5 mg/kg prior to induction with ITRA.
Interventions	Induction phase: ITRA 300 mg BD for 3 days then 200 mg BD for 12 weeks Maintenance phase: ITRA dose reduced to 200 mg OD if induction serum levels were at least 4 µg/mL at week 8 or 200 mg BD if blood concentrations were lower.
Outcomes	Death Response to therapy: defined as resolution of clinical signs and symptoms of histoplasmosis. Adverse events.
Age	Mean 33 (range 16–68) years
Setting	USA
Disease severity	People with severe disease excluded. Defined as PO2 < 60 mmHg, SBP < 90 mmHg, or CNS histoplasmosis
Notes	Response to therapy: 50/59 induction phase. Of 9 failures, 2 died; 6 responded to AmB; 1 lost to follow‐up. Relapse of histoplasmosis infection: 2/46 participants at median follow‐up of 87 weeks. 1 due to poor adherence and 1 to concurrent use of rifampicin. Toxicity: 5/46 participants discontinued treatment Mortality: 24/46 (included participants who discontinued treatment before death). Median survival time from start of maintenance estimated at 79 weeks. 1‐year survival rate estimated at 73%.