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| Sponsor: | 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 |
| 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 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002121 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Antidiarrheals Diarrhea Acquired Immunodeficiency Syndrome AIDS-Related Complex N(1),N(14)-bis(ethyl)homospermine |
|
RNA Virus Infections Sexually Transmitted Diseases, Viral Diarrhea Slow Virus Diseases Signs and Symptoms, Digestive Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Acquired Immunodeficiency Syndrome Cardiovascular Agents Antihypertensive Agents Infection |
Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Signs and Symptoms N(1),N(14)-bis(ethyl)homospermine Radiation-Sensitizing Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |