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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002251
First Posted: August 31, 2001
Last Update Posted: June 24, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
June 24, 2005
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No Changes Posted
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A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir
A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir
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.
Not Provided
Interventional
Not Provided
Primary Purpose: Treatment
  • Cytomegalovirus Infections
  • HIV Infections
Drug: Ganciclovir
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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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).
Sexes Eligible for Study: All
13 Years to 60 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002251
059A
ICM 1775
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Hoffmann-La Roche
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NIH AIDS Clinical Trials Information Service
May 1991

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP