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


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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.

Sponsored by: Hoffmann-La Roche
Information provided by: AIDS Clinical Trials Information Service

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:

Concurrent Medication: Excluded:

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.

Study ID Numbers:  059A; ICM 1775
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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August 21, 2008



Page Updated: June 1, 2005
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