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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002251 |
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 |
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Cytomegalovirus Infections HIV Infections |
Drug: Ganciclovir |
Study Type: | Interventional |
Study Design: | Treatment, Pharmacokinetics Study |
Official Title: | A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir |
Ages Eligible for Study: | 13 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have the following:
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:
Prior Medication:
Excluded:
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 |
Study ID Numbers: | 059A, ICM 1775 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002251 History of Changes |
Health Authority: | United States: Food and Drug Administration |
AIDS-Related Opportunistic Infections Ganciclovir Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Biological Availability |
Anti-Infective Agents Opportunistic Infections Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Ganciclovir Antiviral Agents Cytomegalovirus Immunologic Deficiency Syndromes Herpesviridae Infections |
Virus Diseases HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Cytomegalic Inclusion Disease Cytomegalovirus Infections DNA Virus Infections Retroviridae Infections |
Anti-Infective Agents Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Ganciclovir Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Cytomegalovirus Infections DNA Virus Infections Retroviridae Infections |