Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea
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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 1 |
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.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
- ARC or AIDS by CDC criteria.
- Uncontrolled diarrhea unresponsive to high-dose, nonspecific antidiarrheal therapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Known idiopathic ulcerative colitis or Crohn colitis.
- Acute stool-culture-positive bacterial colitis.
- Acute amoebic colitis.
- Pseudomembranous colitis with Clostridium difficile toxin positivity.
- Short-gut syndrome.
- Chronic pancreatitis.
- Ischemic bowel disease.
- Enteroenteric fistulae.
- Other gastrointestinal tract disorders known to cause diarrhea.
- Underlying evidence of immunosuppression other than that related to HIV infection.
- Unable or unwilling to have subcutaneous injections.
- Clinically significant CNS, hepatic, or renal disease.
Concurrent Medication:
Excluded:
- Other experimental antidiarrheal drugs.
- Antibiotic therapy.
Prior Medication:
Excluded:
- Other experimental drugs within 1 month prior to study entry.
Required:
- At least 2 weeks of prior high-dose, nonspecific antidiarrheal therapy (i.e., loperamide, diphenoxylate hydrochloride-atropine sulfate, or opiates) at maximally tolerable doses.
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No publications provided
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 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Antidiarrheals Diarrhea Acquired Immunodeficiency Syndrome AIDS-Related Complex N(1),N(14)-bis(ethyl)homospermine |
Additional relevant MeSH terms:
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 |
ClinicalTrials.gov processed this record on March 07, 2013