A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir

Exclusion Criteria

• •Co-existing Condition:
• •Patients with the following are excluded:
• •Macular involvement due to cytomegalovirus (CMV) retinitis in both eyes.
• •Active CMV retinitis in which there is progression.
• •Presence of diarrhea or other clinically significant or uncontrolled gastrointestinal disease including persistent nausea and/or abdominal pain. Diarrhea is defined as \> 3 unformed stools/day.
• •Dementia or decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the patient to follow the protocol, to take assigned dose regimen reliably, and to keep a daily record on a calendar.
• •Significant CMV disease of other organs, including CMV gastroenteritis or CMV pneumonia.
• •Concurrent Medication:
• •Excluded:
• •Any investigational drug.
• •Acyclovir not specifically allowed.
• •Any other nucleoside analog.
• •Zidovudine (AZT).
• •Probenecid.
• •Aspirin.
• •Patients with the following are excluded:
• •Macular involvement due to cytomegalovirus (CMV) retinitis in both eyes.
• •Active CMV retinitis in which there is progression.
• •CMV end organ disease.
• •Presence of diarrhea or other clinically significant or uncontrolled gastrointestinal disease including persistent nausea and/or abdominal pain. Diarrhea is defined as \> 3 unformed stools/day.
• •Dementia or decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the patient to follow the protocol, to take assigned dose regimen reliably, and to keep a daily record on a calendar.
• •Significant CMV disease of other organs, including CMV gastroenteritis or CMV pneumonia.
• •Prior Medication:
• •Excluded within 4 days of study entry:
• •Antimetabolite.
• •Interferon.
• •Other nucleoside analog including zidovudine (AZT).
• •Excluded for Group A:
• •Ganciclovir or other anti-cytomegalovirus therapy.