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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002251
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1991
  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 Intervention
Cytomegalovirus Infections
HIV Infections
Drug: Ganciclovir

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
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 NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 20
  Eligibility

Ages Eligible for Study:   13 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002251

Locations
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

Publications:
ClinicalTrials.gov Identifier: NCT00002251     History of Changes
Other Study ID Numbers: 059A, ICM 1775
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014