A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Keywords

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Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Topical or ophthalmic nucleoside analogs.
• Patients must have:
• • Confirmation of HIV infection.
• • Documented CMV infection.
• • No past or present CMV disease (e.g., retinitis, colitis, esophagitis).
• • Adequate visualization of the retina of both eyes by ophthalmologist.
• • CD4 count \<= 50 cells/mm3 (in patients WITHOUT a history of an AIDS-defining opportunistic infection or chronic gynecologic infection) OR CD4 count \<= 100 cells/mm3 (in patients WITH a history of an AIDS-defining opportunistic infection or chronic gynecologic infection).
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Presence of gastrointestinal disease or symptoms not controlled with medications (e.g., persistent nausea, abdominal pain or persistent diarrhea within the past 4 weeks that is not controllable with medication).
• • Inability to comply with protocol.
• Concurrent Medication:
• Excluded:
• * The following nucleoside analogs:
• • IV ganciclovir, IV acyclovir for more than 2 weeks total duration, oral acyclovir at doses \> 1000 mg/day, vidarabine, amantadine hydrochloride, cytarabine, idoxuridine.
• • FIAU, FIAC, foscarnet, CMV hyperimmune globulin, IV immune globulin, CMV monoclonal antibody, HPMPC.
• • Imipenem-cilastatin (Primaxin).
• Patients with the following prior condition are excluded:
• • History of hypersensitivity to acyclovir.
• Prior Medication:
• Excluded within the past 60 days:
• • Ganciclovir, foscarnet, FIAC, FIAU, CMV hyperimmune globulin, CMV monoclonal antibody, or HPMPC.