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

Roche

Status: Completed

Conditions: HIV Infections; Cytomegalovirus Infections

Treatments: Drug: Ganciclovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002251

ICM 1775

059A

Details and patient eligibility

About

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.

Sex: All

Ages: 13 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).