Objective: To report the results of a phase I trial to evaluate the safety
and efficacy of atovaquone for the treatment of ocular toxoplasmosis in imm
unocompetent patients.
Design: Open label, nonrandomized, prospective, clinical trial.
Participants: Seventeen immunocompetent patients between the ages of 18 and
75 years with clinical and serologic evidence of ocular toxoplasmosis part
icipated.
Intervention: Treatment of ocular toxoplasmosis with atovaquone tablets (75
0 mg four times a day) for 3 months. Prednisone (40 mg) tablets were added
on day 3 of treatment and tapered as inflammation resolved.
Main Outcome Measures: Clinical response and patient tolerance to atovaquon
e therapy for ocular toxoplasmosis,
Results: Average follow-up was 10 months, Most patients experienced no adve
rse treatment effects. When present, side effects were usually mild and inc
luded rash, pruritus, headache, and nausea. With the exception of one patie
nt, who discontinued treatment at 6 weeks secondary to persistent epigastri
c discomfort, all patients completed the 12 weeks of therapy. All patients
had a favorable response to treatment that began within 1 to 3 weeks. Visua
l acuity was stabilized or improved in all patients. Median initial visual
acuity was 20/200 and median final visual acuity was 20/25, In general, ato
vaquone was well tolerated.
Conclusions: Atovaquone is better tolerated than conventional antitoxoplasm
osis therapy and appears to be at least as effective. Atovaquone is a promi
sing alternative for the treatment of ocular toxoplasmosis in immunocompete
nt patients.