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Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea



Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

For Condition: Diarrhea,HIV Infections
Status: Completed
Sponsor(s): VA Medical Center-Gainesville ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

Gainesville Veterans Administration Med Ctr
Gainesville,  Florida,  32608
United States
 


Additional Information:
Study ID Numbers:
  223A; 
Study Start Date: 
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002121

Other Hiv Infections Studies:
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3. Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen

4. A Study of Saquinavir and Zalcitabine, Used Alone and Together, in the Treatment of Advanced HIV Infection in Patients Who Stopped Taking or Who Cannot Take Zidovudine

5. Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen

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Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

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