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

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ClinicalTrials.gov Identifier: NCT00002251
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
Cytomegalovirus Infections HIV Infections Drug: Ganciclovir

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Primary Purpose: Treatment
Official Title: A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


  • 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:


  • 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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002251

United States, California
Davies Med Ctr
San Francisco, California, United States, 94114
United States, District of Columbia
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Hoffmann-La Roche
More Information

ClinicalTrials.gov Identifier: NCT00002251     History of Changes
Other Study ID Numbers: 059A
ICM 1775
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 1991

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Biological Availability

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Cytomegalovirus Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action