Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diarrhea HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Diethylhomospermine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Gainesville Veterans Administration Med Ctr

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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223A

Identifier Type: -

Identifier Source: org_study_id