Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Diethylhomospermine

About this trial

This is an interventional treatment trial for Diarrhea focused on measuring Antidiarrheals, Diarrhea, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, N(1),N(14)-bis(ethyl)homospermine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Gainesville Veterans Administration Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002121

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

VA Medical Center-Gainesville

1. Study Identification

Unique Protocol Identification Number

NCT00002121

Brief Title

Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

Official Title

Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

Study Type

Interventional

2. Study Status

Record Verification Date

April 1996

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

VA Medical Center-Gainesville

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diarrhea, HIV Infections

Keywords

Antidiarrheals, Diarrhea, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, N(1),N(14)-bis(ethyl)homospermine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Masking

None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Diethylhomospermine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Facility Information:

Facility Name

Gainesville Veterans Administration Med Ctr

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

Diarrhea, HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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