Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Open Label, Safety Study

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.

Intervention(s) in this Clinical Trial

• Drug: Diethylhomospermine

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: VA Medical Center-Gainesville

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002121

Study ID Number: 223A

ClinicalTrials.gov Identifier: NCT00002121

Health Authority: United States: Food and Drug Administration