Completed

DEHSPM for Reduction of Stool Volume and Frequency in Refractory AIDS-Related Diarrhea

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What is being tested

Diethylhomospermine

Drug
Who is being recruted

Blood-Borne Infections+18

+ Urogenital Diseases

+ Genital Diseases

From 18 to 65 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorVA Medical Center-Gainesville
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorVA Medical Center-Gainesville
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSigns and SymptomsSigns and Symptoms, DigestiveSlow Virus DiseasesPathological Conditions, Signs and SymptomsVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexDiarrheaHIV Infections

Criteria

3 inclusion criteria required to participate
ARC or AIDS by CDC criteria

At least 2 weeks of prior high-dose, nonspecific antidiarrheal therapy (i.e., loperamide, diphenoxylate hydrochloride-atropine sulfate, or opiates) at maximally tolerable doses

Uncontrolled diarrhea unresponsive to high-dose, nonspecific antidiarrheal therapy

15 exclusion criteria prevent from participating
Acute amoebic colitis

Acute stool-culture-positive bacterial colitis

Antibiotic therapy

Chronic pancreatitis

Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Gainesville Veterans Administration Med Ctr

Gainesville, United StatesOpen Gainesville Veterans Administration Med Ctr in Google Maps
CompletedOne Study Center