Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

HIV Infections Clinical Trial

Official title:

Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002121
• Other study ID #: 223A
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• HIV Infections

Intervention

Drug:
• Diethylhomospermine

Locations

Country	Name	City	State
United States	Gainesville Veterans Administration Med Ctr	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Medical Center-Gainesville

Country where clinical trial is conducted

United States,