Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002121
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

Resource links provided by NLM:


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

No publications provided

ClinicalTrials.gov Identifier: NCT00002121     History of Changes
Other Study ID Numbers: 223A
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Diarrhea
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
N(1),N(14)-bis(ethyl)homospermine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014