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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Cytomegalovirus Infections HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Ganciclovir

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

13 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Davies Med Ctr

San Francisco, California, United States

Site Status

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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Lavelle J, Follansbee S, Trapnell CB, Buhles WC, Griffy KG, Jung D, Dorr A, Connor J. Effect of food on the relative bioavailability of oral ganciclovir. J Clin Pharmacol. 1996 Mar;36(3):238-41. doi: 10.1002/j.1552-4604.1996.tb04193.x.

Reference Type BACKGROUND

PMID: 8690817 (View on PubMed)

Other Identifiers

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ICM 1775

Identifier Type: -

Identifier Source: secondary_id

059A