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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT00002251

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cytomegalovirus Infections HIV Infections	Drug: Ganciclovir	N/A

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).