Long-term follow-up of patients with AIDS treated with parenteral cidofovir for cytomegalovirus retinitis: the HPMPC Peripheral Cytomegalovirus Retinitis Trial - The Studies of Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group

Objective: To evaluate patients with cytomegalovirus (CMV) retinitis treate d with intravenous cidofovir for long-term outcomes. Design: Patients with CMV retinitis enrolled in a randomized, controlled cl inical trial of intravenous cidofovir as treatment for retinitis were follo wed for long-term outcomes, including 21 patients initially enrolled in the deferral group who received cidofovir therapy after progression of retinit is. Setting: Thirteen tertiary care clinics specializing in AIDS care and ophth almology. Participants: Fifty-eight patients with AIDS and small peripheral CMV retin itis lesions. Interventions: Cidofovir 5 mg/kg once weekly for 2 weeks followed by low-do se maintenance cidofovir therapy (3 mg/kg) in 35 patients or high-dose main tenance (5 mg/kg) in 23 patients. Main outcome measures: Time to progression of retinitis, drug toxicities. Results: Median time to progression of retinitis was 2.5 months. Median tim e to discontinuation of cidofovir because of intolerance was 6.6 months, an d did not differ significantly between the two maintenance doses. Median ti me to discontinuation of cidofovir for intolerance other than probenecid re action was 16.3 months for patients treated with low-dose maintenance and 5 .0 months for patients treated with high-dose maintenance (P = 0.021). Prot einuria of 2+ or more occurred at a rate of 1.22/person year. In patients w ith sufficient follow-up to determine resolution of proteinuria, 89.9% of e pisodes resolved, and the median time to resolution was 20 days. Rates of p robenecid intolerance and of cidofovir-associated uveitis were 0.35/person- year, and 0.20/person-year, respectively.