Completed
Sandostatin Efficacy and Safety in HIV-Related Diarrhea Treatment
Study Aim
This study aims to evaluate the safety and effectiveness of Sandostatin in treating HIV-related diarrhea.
What is being tested
Octreotide
Drug
Who is being recruted
Blood-Borne Infections+18
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+12 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorSandoz
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
To determine the efficacy and safety of Sandostatin (octreotide) compared to placebo in controlling diarrhea which is a manifestation or complication of documented HIV infection and which is refractory (does not respond) to all known treatment classes.
Principal SponsorSandoz
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.Over 18 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
5 inclusion criteria required to participate
Ability to communicate, participate, and comply with the requirements of the study
At least two weeks of conventional dosing regimens of antidiarrheal medication (e.g.: Lomotil, Imodium, Paregoric) within one month prior to study entry. OR Patients with evidence of upper or lower GI infection(s) for which there is approved, potentially curative therapy must have failed appropriate treatment for at least two weeks
Capability of self administering injections of study medication or have responsible family member or companion who can
Given written consent prior to study entry
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7 exclusion criteria prevent from participating
Diarrhea caused by a known gastrointestinal disorder such as idiopathic ulcerative colitis, Crohn's disease, acute stool culture positive bacterial colitis (documented within the last 2 weeks prior to study entry AND not having at least 2 weeks of antibiotic therapy), pseudomembranous colitis (Clostridium difficile toxin positive), short gut syndrome, chronic pancreatitis (alcoholic or idiopathic), ischemic bowel disease, or enteroenteric fistulae
Diarrhea that can be controlled with conventional antidiarrheal agents
Evidence of underlying immunosuppressive disease other than due to HIV
Experimental antidiarrheal drugs within one month of study entry
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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 23 locations
UCSD Med Ctr
San Diego, United StatesUCSF - San Francisco Gen Hosp
San Francisco, United StatesKaiser Permanente Med Ctr
San Francisco, United StatesCompleted23 Study Centers