Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea
Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea
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.
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.
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.