Diarrhea |
Dysentery |
Clinical Trial: Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea
This study has been completed.
|
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
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
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

Not Signed In -


