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Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

This study has been completed.

Sponsored by: VA Medical Center-Gainesville
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002121
  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 Intervention Phase
Diarrhea
HIV Infections
Drug: Diethylhomospermine
Phase I

MedlinePlus related topics:   AIDS   Diarrhea  

ChemIDplus related topics:   Loperamide   Loperamide hydrochloride   N(1),N(14)-Bis(ethyl)homospermine  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Safety Study
Official Title:   Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

Further study details as provided by NIH AIDS Clinical Trials Information Service:

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.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002121

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

Sponsors and Collaborators
VA Medical Center-Gainesville
  More Information

Study ID Numbers:   223A
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002121
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Antidiarrheals  
Diarrhea  
Acquired Immunodeficiency Syndrome  
AIDS-Related Complex  
N(1),N(14)-bis(ethyl)homospermine  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
N(1),N(14)-bis(ethyl)homospermine
Diarrhea
Signs and Symptoms, Digestive
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Loperamide
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Infection
Antihypertensive Agents
Pharmacologic Actions
Virus Diseases
Signs and Symptoms
Radiation-Sensitizing Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on July 03, 2008




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