Ganciclovir Oral |
Cytoveve Capsules |
Clinical Trial: A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir
This study has been completed.
|
Purpose
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 | Treatment or Intervention |
|---|---|
| Cytomegalovirus Infections HIV Infections | Drug: Ganciclovir |
MedlinePlus related topics: AIDS; Cytomegalovirus Infections
Study Type: Interventional
Study Design: Treatment, Pharmacokinetics Study
Eligibility
Ages Eligible for Study: 13 Years - 60 Years, Genders Eligible for Study: Both
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).
Location Information
California
Davies Med Ctr, San Francisco, California, 94114, United States
District of Columbia
Georgetown Univ Med Ctr, Washington, District of Columbia, 20007, United States
More Information
Publications
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.
Record last reviewed: May 1991
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00002251
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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