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| Sponsored by: |
Hoffmann-La Roche |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002096 |
Purpose
To determine whether there is a pharmacokinetic drug interaction between oral ganciclovir and oral zidovudine (AZT) and between oral ganciclovir and oral didanosine (ddI). To determine whether concurrent administration of probenecid affects the pharmacokinetics of oral ganciclovir. To obtain data on the short-term safety of oral ganciclovir administered concurrently with AZT, ddI, or probenecid in HIV-positive patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Cytomegalovirus Infections HIV Infections |
Drug: Zidovudine Drug: Didanosine Drug: Ganciclovir |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Required:
OR
Contacts and Locations| United States, California | |
| Ctr for Special Immunology | |
| Irvine, California, United States, 92718 | |
| United States, District of Columbia | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Texas | |
| Univ TX Galveston Med Branch | |
| Galveston, Texas, United States, 77550 | |
More Information
| Study ID Numbers: | 059E, ICM 1776 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002096 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Didanosine Ganciclovir Drug Interactions |
Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Zidovudine |
|
Antimetabolites Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Zidovudine Ganciclovir Antiviral Agents Cytomegalovirus Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Herpesviridae Infections |
Virus Diseases Didanosine Anti-Retroviral Agents HIV Seropositivity HIV Infections Sexually Transmitted Diseases Cytomegalic Inclusion Disease Cytomegalovirus Infections DNA Virus Infections Retroviridae Infections |
|
Antimetabolites Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Cytomegalovirus Infections Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Ganciclovir Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Herpesviridae Infections Virus Diseases Didanosine HIV Infections Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections |