Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Medical Center-Gainesville
• Treatments: N(1),N(14)-bis(ethyl)homospermine

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.