A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure
Condition: Cytomegalovirus Retinitis; HIV Infections
MeSH terms: Infections; Cytomegalovirus Retinitis; Retinitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To examine the usefulness and safety of the antiviral drug foscarnet in treating AIDS
      patients with cytomegalovirus (CMV) infection that is causing sight-threatening inflammation
      of the retina in one or both eyes (CMV retinitis). Because of the seriousness of
      sight-threatening CMV retinitis in AIDS patients and a lack of other available treatments for
      those patients who cannot be treated with ganciclovir (DHPG) (because of its toxic effect on
      the body's blood-forming cells, because it did not control the disease, or because patient's
      blood cell or platelet counts are too low to begin with), it is worthwhile to try an
      immediate trial with foscarnet. AMENDED: ACTG 093 was originally designed as a randomized
      dose-ranging study of foscarnet maintenance therapy. Patients enrolled between March 17,
      1989, and January 1, 1990, received either 60 mg/kg/day or 90/mg/kg day as maintenance
      therapy following the 2 week induction period. Based on the preliminary results of ACTG
      015/915, which studied maintenance doses of foscarnet of 60 mg/kg/day, 90 mg/kg/day and 120
      mg/kg/day, the 60-mg/kg/day and 90/mg/kg/day arms of this study have been closed. All
      patients entering the study beginning January 2, 1990 will receive foscarnet maintenance
      therapy on a 120/mg/kg/day algorithm following induction.
    

Detailed description: 
      Because of the seriousness of sight-threatening CMV retinitis in AIDS patients and a lack of
      other available treatments for those patients who cannot be treated with ganciclovir (DHPG)
      (because of its toxic effect on the body's blood-forming cells, because it did not control
      the disease, or because patient's blood cell or platelet counts are too low to begin with),
      it is worthwhile to try an immediate trial with foscarnet. AMENDED: ACTG 093 was originally
      designed as a randomized dose-ranging study of foscarnet maintenance therapy. Patients
      enrolled between March 17, 1989, and January 1, 1990, received either 60 mg/kg/day or
      90/mg/kg day as maintenance therapy following the 2 week induction period. Based on the
      preliminary results of ACTG 015/915, which studied maintenance doses of foscarnet of 60
      mg/kg/day, 90 mg/kg/day and 120 mg/kg/day, the 60-mg/kg/day and 90/mg/kg/day arms of this
      study have been closed. All patients entering the study beginning January 2, 1990 will
      receive foscarnet maintenance therapy on a 120/mg/kg/day algorithm following induction.

      AMENDED: The ACTG 093 optional extended maintenance therapy period will conclude on January
      2, 1991 in order to facilitate timely analysis of this study. All patients who wish to
      continue foscarnet therapy should be referred to Astra Protocol 90-FOS-14 at telephone number
      800-292-5775. Original design: Patients are placed into two groups: (1) patients who have a
      sight-threatening lesion in the retina of an eye with vision that can be saved (corrected
      vision of 20/100 or better) and who cannot be treated with DHPG, and (2) patients whose
      retinitis has quickly gotten worse and/or has shown resistance to DHPG treatment. Both groups
      will receive a beginning (induction) dose of foscarnet by vein (IV) for 2 weeks, followed by
      a maintenance dose for 8 weeks with an option to continue up to 24 weeks. AMENDED: Patients
      entering the study on or after 01/02/90 receive the standard two week course of foscarnet
      induction therapy and receive maintenance therapy. Treatment is given for a ten week study
      period or until progression occurs or toxicity endpoints are reached. If retinitis is stable
      and foscarnet well-tolerated, maintenance therapy may be extended for a period not to exceed
      1 year.
    

Intervention name(s): Foscarnet sodium
Intervention type(s): Drug
Intervention MeSH terms: Foscarnet; Phosphonoacetic Acid
Primary purpose: Treatment
Keywords: Retinitis; AIDS-Related Opportunistic Infections; Ganciclovir; Drug Evaluation; Foscarnet; Cytomegalovirus Infections; Acquired Immunodeficiency Syndrome; Antiviral Agents