A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Keywords

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Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must have the following:
• • Confirmation of HIV infection by HIV antibody testing, p24 antigen, or culture of HIV.
• • Documented confirmation of present or past CMV infection.
• • Must understand the nature of the study, agree to tests required in the protocol, and must understand and sign an informed Consent form approved by the appropriate Institutional Review Board and by Syntex.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• • Uncontrolled diarrhea or clinically significant gastrointestinal symptoms including persistent nausea or abdominal pain.
• Concurrent Medication:
• Excluded:
• • Antimetabolites. Interferons. Other nucleoside analogs. Zidovudine (AZT). Any investigational drug.
• Patients with the following are excluded:
• • Any concomitant conditions listed in Exclusion Co-Existing Conditions.
• • Karnofsky score \< 70.
• • Hypersensitivity to acyclovir.
• • Displaying signs of dementia or decreased mentation which would interfere with the ability of the subject to follow protocol schedule.
• Prior Medication:
• Excluded:
• • Anti-cytomegalovirus therapy including ganciclovir therapy for treatment of CMV disease.
• * Excluded within 4 days of study entry:
• • Antimetabolites.
• • Interferons.
• • Other nucleoside analogs.
• • Zidovudine (AZT).