Completed

SP-303 for Diarrhea Reduction in AIDS Patients

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What is being tested

Crofelemer

Drug
Who is being recruted

Blood-Borne Infections+17

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorShaman Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on a treatment called SP-303 for individuals living with AIDS who experience diarrhea. The main goal is to understand if SP-303 can effectively reduce diarrhea symptoms, specifically by decreasing stool weight. The research also aims to evaluate the safety of SP-303 and how long its effects last. This study is important as it could potentially offer a new treatment option for AIDS patients dealing with diarrhea, thereby improving their quality of life. In this study, participants receive SP-303 orally over a period of 6 days. The study is designed as 'double-blind', meaning neither the participants nor the researchers know who is receiving the actual drug or a placebo, a pill without any active ingredients. This helps ensure the results are unbiased. The effectiveness of SP-303 is measured by monitoring changes in stool weight. Safety is evaluated by tracking any side effects or health changes throughout the study period.

NCT00002408
Principal SponsorShaman Pharmaceuticals
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.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

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 SyndromeDiarrheaHIV Infections

Criteria

3 inclusion criteria required to participate
HIV infection meeting CDC criteria for AIDS.

On stable medical regimen.

History of diarrhea for greater than or equal to 14 days prior to screening period (Day 1).

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 36 locations

Hill Top Research Ltd

Scottsdale, United StatesOpen Hill Top Research Ltd in Google Maps

Phoenix Living Ctr

Scottsdale, United States

UCLA Care Ctr

Los Angeles, United States

AIDS Research Ctr / Dept of Veterans Affairs

Palo Alto, United States
Completed36 Study Centers