Design of clinical trials for drug combinations: cytomegalovirus retinitis--foscarnet and ganciclovir. The CMV retinitis retreatment trial.
The Cytomegalovirus Retinitis Retreatment Trial was a multicenter clinical trial designed to evaluate three treatments for the treatment of relapsed CMV retinitis; (1) foscarnet; (2) 'high-dose' ganciclovir, and (3) combination foscarnet and ganciclovir. Two hundred seventy-nine patients were enrolled and randomly assigned to one of these three regimens. Patients were followed monthly for 6 months and every 3 months thereafter. Outcomes of interest included: (1) mortality; (2) retinitis progression; (3) change in retinal area affected by CMV; (4) loss of visual field; (5) loss of visual acuity; (6) quality of life; and (7) treatment side effects.
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Johns Hopkins University School of Medicine, Baltimore, MD 21212, USA.
D000163:Acquired Immunodeficiency Syndrome / Q000150:complications / Q000188:drug therapy / Q000401:mortality; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use; D017726:Cytomegalovirus Retinitis / Q000188:drug therapy* / Q000401:mortality; D018450:Disease Progression; D004359:Drug Therapy, Combination; D017245:Foscarnet / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015774:Ganciclovir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D012107:Research Design
D000998:Antiviral Agents; D017245:Foscarnet; D015774:Ganciclovir