Design of clinical trials for drug combinations: cytomegalovirus retinitis--foscarnet and ganciclovir. The CMV retinitis retreatment trial

Antiviral Res. 1996 Jan;29(1):69-71. doi: 10.1016/0166-3542(95)00921-3.

Abstract

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Acquired Immunodeficiency Syndrome / complications
  • Acquired Immunodeficiency Syndrome / drug therapy
  • Acquired Immunodeficiency Syndrome / mortality
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use
  • Cytomegalovirus Retinitis / drug therapy*
  • Cytomegalovirus Retinitis / mortality
  • Disease Progression
  • Drug Therapy, Combination
  • Foscarnet / administration & dosage
  • Foscarnet / adverse effects
  • Foscarnet / therapeutic use*
  • Ganciclovir / administration & dosage
  • Ganciclovir / adverse effects
  • Ganciclovir / therapeutic use*
  • Humans
  • Multicenter Studies as Topic
  • Randomized Controlled Trials as Topic*
  • Research Design*

Substances

  • Antiviral Agents
  • Foscarnet
  • Ganciclovir