Diarrhea, HIV Infections
Conditions
Keywords
Antidiarrheals, Diarrhea, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, N(1),N(14)-bis(ethyl)homospermine
Brief 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.
Detailed 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.
Interventions
DRUGDiethylhomospermine
Sponsors
VA Medical Center-Gainesville
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed