Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Ganciclovir
Ganciclovir triphosphate
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).