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| Sponsored by: |
VA Medical Center-Gainesville |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002121 |
Purpose
To perform preliminary clinical testing of diethylhomospermine (DEHSPM), a polyamine analogue, for refractory AIDS-related diarrhea.
Possibly, DEHSPM will reduce stool volume and frequency in patients with refractory AIDS-related diarrhea.
| Condition | Intervention | Phase |
|
Diarrhea HIV Infections |
Drug: Diethylhomospermine |
Phase I |
| MedlinePlus related topics: | AIDS Diarrhea |
| ChemIDplus related topics: | Loperamide Loperamide hydrochloride N(1),N(14)-Bis(ethyl)homospermine |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Safety Study |
| Official Title: | Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea |
Possibly, DEHSPM will reduce stool volume and frequency in patients with refractory AIDS-related diarrhea.
Patients are initially hydrated for 24 hours, followed by a 3-day baseline period. They then receive intravenous infusions of DEHSPM three times per day for 3 days, followed by observation for 3 days.
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded:
Required:
Contacts and Locations
More Information
| Study ID Numbers: | 223A |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002121 |
| Health Authority: | United States: Food and Drug Administration |
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