Expired Study
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Gainesville, Florida 32608


Purpose:

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 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.


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.


NCT ID:

NCT00002121


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Gainesville, Florida 32608
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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