Cytomegalovirus Retinitis, HIV Infections
Conditions
Keywords
Retinitis, Ganciclovir, Administration, Oral, Acquired Immunodeficiency Syndrome
Brief summary
To demonstrate the efficacy of oral ganciclovir in preventing new cytomegalovirus (CMV) disease in AIDS patients with unilateral CMV retinitis treated with an intravitreal ganciclovir implant. To compare safety and tolerance, time to progression, quality of life, and survival among patients treated with an intravitreal ganciclovir implant, with and without oral ganciclovir, versus standard intravenous (IV) ganciclovir therapy.
Detailed description
Patients receive intravitreal ganciclovir implant plus oral ganciclovir, intravitreal implant alone, or IV ganciclovir.
Interventions
DRUGGanciclovir
Sponsors
Roche Global Development
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Concurrent Medication: Allowed: * Topical drugs and ophthalmics. Patients must have: * AIDS. * Unilateral CMV retinitis.
Exclusion criteria
Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Chronic, clinically significant diarrhea, nausea, abdominal pain,or other symptoms of uncontrolled gastrointestinal disease. * Ocular opacities (corneal, aqueous, lens, or vitreous) preventing ophthalmologic retinal assessment of fundus photography. * Acute retinal necrosis or any other intraocular condition that might preclude study completion. * Ocular condition requiring immediate surgery. * Unable to have long-term IV catheter placement. Concurrent Medication: Excluded: * Vidarabine. * Amantadine hydrochloride. * Cytarabine. * FIAC or FIAU. * Idoxuridine. * Ribavirin. * Valacyclovir. * Foscarnet. * CMV hyperimmune globulin. * Soluble CD4. * Trichosanthin. * Imipenem-cilastatin. * Isoprinosine. * Levamisole. * Interferon. * Other investigational drugs. Patients with the following prior conditions are excluded: * History of previous invasive intraocular surgery of any kind in the involved eye or any condition for which ocular surgery is contraindicated. * History of hypersensitivity to acyclovir or ganciclovir. Prior Medication: Excluded: * Any prior oral ganciclovir in a CMV retinitis treatment protocol OR more than 4 months of prior oral ganciclovir in a prophylaxis study (per amendment). * Prior intravitreal ganciclovir implant. * More than two prior induction dose courses of IV anti-CMV therapy (per amendment). * Intravitreal injection of any antiviral medication within the past 4 weeks (per amendment).
Countries
United States
Outcome results
None listed