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Efficacy and Safety of Low-dose Cidofovir in HIV-Associated CMV Retinitis: Results of a Phase III, Randomized, Double-blind, Placebo-controlled Trial.
There is growing interest in a potential role of antivirals in management of cytomegalovirus (CMV) retinitis. We aimed to assess the efficacy and safety of low-dose cidofovir in HIV-associated CMV retinitis (HIV-CMVR). Adults with HIV-CMVR and non-infectious end-organ disease were randomized 1:1 to receive low-dose cidofovir (3.5 mg/kg, intravenously, daily) or matching placebo for a maximum of 9 months. The primary outcome was the proportion of participants in each group achieving a complete or partial response at week 12. Randomized participants (n = 89) were studied: 57 (64%) received cidofovir and 32 (36%) placebo. The median time to response (time to first CMV-DNA-negative urine specimen) was significantly shorter in the cidofovir group (14 days) than in the placebo group (21 days) (P = 0.02). The cidofovir group had a higher response rate (47.4% vs. 19.4%, P = 0.007) and a higher proportion with a complete or partial response at week 12 (62.5% vs. 29.4%, P = 0.006) than the placebo group. The overall mean change in log(10) CMV-DNA in the plasma after 12 weeks was -1.1 log(10) in the cidofovir group and -0.5 log(10) in the placebo group (P = 0.03). Drug-related adverse events were
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