A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy
Condition: Cytomegalovirus Retinitis; HIV Infections
MeSH terms: Infections; Cytomegalovirus Retinitis; Retinitis
Study type: Interventional
Phase: Phase 1

Summary: 
      AMENDED: 04-12-91 Population of patients changed FROM those who are intolerant of systemic
      therapy with NON-sight-threatening CMV retinitis TO those AIDS patients intolerant of
      systemic therapy with CMV retinitis.

      AMENDED: 8/8/90. Changes made in neutrophils count from < 500 to < 750 cells/mm3.
      Nonrandomized eyes will not be used for the primary efficacy evaluation.

      ORIGINAL DESIGN: To determine the effectiveness and safety of ganciclovir (DHPG) therapy in
      AIDS patients suffering from active cytomegalovirus (CMV) infection of the retina of the eye
      (retinitis) when the drug is administered directly into the fluid-filled vitreous cavity of
      the eye by injection.

      CMV retinitis is the most frequently seen opportunistic infection of the eye in AIDS
      patients, and left untreated can lead to severe visual loss and blindness. While systemic
      administration of DHPG has been shown to be an effective treatment for CMV retinitis, the
      chronic administration required may be complicated by decreased blood cell counts
      (granulocytopenia) which may require discontinuation of treatment. While withholding
      treatment may allow recovery from the granulocytopenia, interruption of therapy may result in
      reactivation of the retinitis. Injection of DHPG into the vitreous cavity of the eye may be
      of benefit to severely neutropenic patients with CMV retinitis.
    

Detailed description: 
      CMV retinitis is the most frequently seen opportunistic infection of the eye in AIDS
      patients, and left untreated can lead to severe visual loss and blindness. While systemic
      administration of DHPG has been shown to be an effective treatment for CMV retinitis, the
      chronic administration required may be complicated by decreased blood cell counts
      (granulocytopenia) which may require discontinuation of treatment. While withholding
      treatment may allow recovery from the granulocytopenia, interruption of therapy may result in
      reactivation of the retinitis. Injection of DHPG into the vitreous cavity of the eye may be
      of benefit to severely neutropenic patients with CMV retinitis.

      Patients must have active CMV retinitis in one or both eyes, despite prior systemic therapy.
      Following medical evaluation, the decision is made whether to treat the eye(s) immediately or
      to watch the eye(s) carefully for advancement of the retinitis. Eyes with sight-threatening
      lesions or eyes without functional vision are treated immediately and eyes without
      sight-threatening lesions are randomly chosen for either immediate or deferred therapy. DHPG
      is given by injection with a very fine needle twice a week for the first 3 weeks and once a
      week for the remaining 24 weeks.
    

Intervention name(s): Ganciclovir
Intervention type(s): Drug
Intervention MeSH terms: Ganciclovir; Ganciclovir triphosphate
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Retinitis; AIDS-Related Opportunistic Infections; Ganciclovir; Cytomegalovirus Infections; Acquired Immunodeficiency Syndrome