Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

Sponsor

VA Medical Center-Gainesville (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00002121

Collaborator

(none)

Location

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diarrhea HIV Infections	Drug: Diethylhomospermine	Phase 1

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.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.