Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea
VA Medical Center-Gainesville
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1996
History of Changes
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.
Drug : Diethylhomospermine
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Possibly, DEHSPM will reduce stool volume and frequency in patients with refractory
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.
|Ages Eligible for Study:||18 Years to 65 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients must have:
- ARC or AIDS by CDC criteria.
- Uncontrolled diarrhea unresponsive to high-dose, nonspecific antidiarrheal therapy.
- 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.
- Other experimental antidiarrheal drugs.
- Antibiotic therapy.
- Other experimental drugs within 1 month prior to study entry.
- At least 2 weeks of prior high-dose, nonspecific antidiarrheal therapy (i.e.,
Patients with the following symptoms or conditions are excluded:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002121
Locations Show More
|United States, Florida|
|Gainesville Veterans Administration Med Ctr|
|Gainesville, Florida, United States, 32608|
Sponsors and CollaboratorsVA Medical Center-Gainesville
|Responsible Party:||VA Medical Center-Gainesville|
|ClinicalTrials.gov Identifier:||NCT00002121 History of Changes|
|Other Study ID Numbers:||223A|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Antidiarrheals
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.