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

Completed · Not applicable

Conditions studied: Cytomegalovirus Infections, HIV Infections

In brief

This study is designed to determine the influence of food on the absorption and relative bioavailability of oral ganciclovir by comparing the absorption of oral ganciclovir in a fed and fasting state at steady state plasma levels.

Key facts

Study ID

NCT00002251

Run by

Hoffmann-La Roche

People needed

20

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Davies Med Ctr — San Francisco, California, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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