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| Descriptive Information Fields | |
| Brief Title † | A Study of MDL 28,574A in HIV-Infected Patients |
| Official Title † | A Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Oral Dose-Tolerance Study of Oral MDL 28,574A Solution in HIV-Positive Patients |
| Brief Summary | To characterize the safety profile of MDL 28574A following both acute and subchronic dosing in HIV-positive patients. To determine the MTD of both acute and subchronic doses of this drug when administered as oral solution. To determine the pharmacokinetic profile of MDL 28574A and castanospermine (from which MDL 28574A is derived) following both acute and subchronic dosing. |
| Detailed Description | In Part A of the study, patients receive a single oral dose of MDL 28574A on day 1 and are followed through day 7. In Part B, patients receive single daily doses of the drug on days 1 through 14 and are followed through day 21. |
| Study Phase | Phase I |
| Study Type † | Interventional |
| Study Design † | Treatment, Double-Blind, Pharmacokinetics Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | HIV Infections |
| Intervention † | Drug: Celgosivir hydrochloride |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | |
| Start Date † | |
| Completion Date | |
| Eligibility Criteria † | Inclusion Criteria Patients must have:
NOTE:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded:
Concurrent Medication: Excluded:
Patients with the following prior conditions are excluded:
Prior Medication: Excluded:
History of alcohol or drug abuse within the past year. |
| Gender | Both |
| Ages | 18 Years to 50 Years |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00002329 |
| Organization ID | 221A |
| Secondary IDs †† | NDPR0002 |
| Study Sponsor † | Hoechst Marion Roussel |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | May 1995 |
| First Received Date † | November 2, 1999 |
| Last Updated Date | June 23, 2005 |