Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea
Completed · Phase 1
Conditions studied: Diarrhea, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002121
- Run by
- VA Medical Center-Gainesville
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have:
- ARC or AIDS by CDC criteria.
- Uncontrolled diarrhea unresponsive to high-dose, nonspecific antidiarrheal therapy.
You may not qualify if…
- 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.
Where it is running
- Gainesville Veterans Administration Med Ctr — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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