Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

Launched by VA MEDICAL CENTER-GAINESVILLE · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• • 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.