Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

VA Medical Center-Gainesville

Status and phase: Completed; Phase 1

Conditions: Diarrhea; HIV Infections

Treatments: Drug: Diethylhomospermine

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00002121

223A

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.