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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 2, 1999 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00002096 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine |
| Official Title ICMJE | A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine |
| Brief Summary | 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. |
| Detailed Description | Patients currently on either AZT or ddI receive ganciclovir therapy. |
| Study Phase | Phase I |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Safety Study |
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 24 |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | 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:
History of alcoholism (in ddI patients). |
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00002096 |
| Responsible Party | |
| Study ID Numbers ICMJE | 059E, ICM 1776 |
| Study Sponsor ICMJE | Hoffmann-La Roche |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | November 1993 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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