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Clinical Trials

MainTitle

Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

This study has been completed
Sponsor
VA Medical Center-Gainesville


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002121

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1996
History of Changes
Purpose

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

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

Eligibility

Ages Eligible for Study: 18 Years to 65 Years  
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

Contacts and Locations

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, see Learn About Clinical Studies.

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

More Information


Responsible Party: VA Medical Center-Gainesville  
ClinicalTrials.gov Identifier: NCT00002121   History of Changes  
Other Study ID Numbers: 223A  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

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
N(1),N(14)-bis(ethyl)homospermine

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.