Clinical Trials


Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

This study has been completed
VA Medical Center-Gainesville

Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service Identifier

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.

Condition Intervention Phase
HIV Infections

Drug : Diethylhomospermine
Phase 1

Study Type: Interventional
Study Design: 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:

Detailed Description:

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.



Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: All  
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:
  • Other experimental antidiarrheal drugs.
  • Antibiotic therapy.

  • Prior Medication:
  • 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.

contacts and locations

Contacts and Locations

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Please refer to this study by its identifier: NCT00002121


United States, Florida
Gainesville Veterans Administration Med Ctr
Gainesville, Florida, United States, 32608

Sponsors and Collaborators

VA Medical Center-Gainesville
More Information

More Information

Responsible Party: VA Medical Center-Gainesville 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:

Acquired Immunodeficiency Syndrome
AIDS-Related Complex

Additional relevant MeSH terms:
HIV Infections
N(1),N(14)-bis(ethyl)homospermine processed this data on July 20, 2018
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