We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002121
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH 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 Intervention Phase
Diarrhea HIV Infections Drug: Diethylhomospermine Phase 1

Study Type: Interventional
Study Design: Masking: None (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002121


Locations
United States, Florida
Gainesville Veterans Administration Med Ctr
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
VA Medical Center-Gainesville
  More Information

ClinicalTrials.gov Identifier: NCT00002121     History of Changes
Other Study ID Numbers: 223A
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: April 1996

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
Diarrhea
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
N(1),N(14)-bis(ethyl)homospermine
Antihypertensive Agents
Antineoplastic Agents