|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Endpoint Classification: Safety Study Masking: Open Label Primary Purpose: Treatment |
| 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
| ClinicalTrials.gov Identifier: | NCT00002121 History of Changes |
| Other Study ID Numbers: | 223A |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Antidiarrheals Diarrhea Acquired Immunodeficiency Syndrome AIDS-Related Complex N(1),N(14)-bis(ethyl)homospermine |
|
HIV Infections Acquired Immunodeficiency Syndrome Diarrhea Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Signs and Symptoms, Digestive Signs and Symptoms N(1),N(14)-bis(ethyl)homospermine Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents Radiation-Sensitizing Agents Physiological Effects of Drugs |