Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996

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: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

Resource links provided by NLM:

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
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:


  • Other experimental antidiarrheal drugs.
  • Antibiotic therapy.

Prior Medication:


  • Other experimental drugs within 1 month prior to study entry.


  • 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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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

No publications provided 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:
Acquired Immunodeficiency Syndrome
AIDS-Related Complex

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive
Antihypertensive Agents
Antineoplastic Agents
Cardiovascular Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses processed this record on November 25, 2015