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Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea - Article


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Diarrhea

Dysentery


Clinical Trial: Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

This study has been completed.

Sponsored by: VA Medical Center-Gainesville
Information provided by: AIDS Clinical Trials Information Service

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.

Condition Treatment or Intervention Phase
Diarrhea
HIV Infections
 Drug: Diethylhomospermine
Phase I

MedlinePlus related topics:  AIDS;   Diarrhea

Study Type: Interventional
Study Design: Treatment, Open Label, Safety Study

Further Study 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

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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.

Location Information


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

More Information

Study ID Numbers:  223A
Record last reviewed:  April 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002121
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: May 11, 2006
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