DiarrheaPhase 3NCT00002408
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients
A Phase 3 study testing Crofelemer in people with Diarrhea and HIV Infections, run by Shaman Pharmaceuticals at 36 sites in 2 countries.
Trial summary
To evaluate the efficacy, safety, and durability of response of SP-303 in decreasing stool weight in AIDS patients with diarrhea over 6 days of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diarrhea, HIV Infections
- What is being tested?
- Crofelemer
- How many people
- 300 participants
- Where
- 36 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- HIV infection meeting CDC criteria for AIDS.
- History of diarrhea for greater than or equal to 14 days prior to screening period (Day 1).
- Required:
- On stable medical regimen.
Who cannot join
None listed.
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
United States34 sites
Phillip Branchman
Atlanta, Georgia, 30327
Johns Hopkins Hosp
Baltimore, Maryland, 212875554
New England Med Ctr
Boston, Massachusetts, 02111
Brookdale Univ Hosp and Med Ctr
Brooklyn, New York, 112123198
Community CRI of South Florida
Coral Gables, Florida, 33146
Insite Clinical Trials
Decatur, Georgia, 30033
Wayne State Univ
Detroit, Michigan, 48201
Joseph Gathe
Houston, Texas, 77004
Indiana Univ Med Ctr
Indianapolis, Indiana, 462025250
New Orleans Pharmaceutical Research
Kenner, Louisiana, 70062
UCLA Care Ctr
Los Angeles, California, 90095
Central Florida Research Initiative
Maitland, Florida, 32751
Deering Hosp
Miami, Florida, 33157
Hennepin County Med Ctr
Minneapolis, Minnesota, 55415
Saint Vincents Hosp
New York, New York, 10011
Oak Park Hosp
Oak Park, Illinois, 60304
Rosemont Health Care Ctr
Orlando, Florida, 32808
AIDS Research Ctr / Dept of Veterans Affairs
Palo Alto, California, 94304
Wake Med CRI
Raleigh, North Carolina, 27610
Regions Hosp
Saint Paul, Minnesota, 55101
GCRC - VA Hosp
San Antonio, Texas, 78284
South Texas Veterans Health Care System
San Antonio, Texas, 78284
San Francisco Gen Hosp
San Francisco, California, 94110
Hill Top Research Ltd
Scottsdale, Arizona, 85251
Phoenix Living Ctr
Scottsdale, Arizona, 85251
Bailey Boushay House
Seattle, Washington, 98112
Rosehedge House
Seattle, Washington, 98125
Washington Univ School of Medicine
St Louis, Missouri, 63110
Ctr for Quality Care
Tampa, Florida, 33609
Mem Hosp of Tampa
Tampa, Florida, 33609
Howard Univ
Washington D.C., District of Columbia, 20059
GCRC
Washington D.C., District of Columbia, 20060
Lynn House Hospice
West Hollywood, California, 90046
AIDS Research Alliance
West Hollywood, California, 90069
Puerto Rico2 sites
Hosp Regional de Ponce
Ponce, 00731
Clinical Research Puerto Rico Inc
San Juan, 00909
About this study
To evaluate the efficacy, safety, and durability of response of SP-303 in decreasing stool weight in AIDS patients with diarrhea over 6 days of treatment.
- Conditions
- Diarrhea, HIV Infections
- Being tested
- Crofelemer
- Keywords
- Diarrhea, Acquired Immunodeficiency Syndrome
- Medical subject headings
- Diarrhea, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrofelemerDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Shaman Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002408
- Sponsor's protocol ID
- 293A
- Other IDs
- 37,554-210
- Status last verified
- Apr 1999
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients
- ClinicalTrials.gov ID
- NCT00002408
- Acronym / sponsor ID
- 293A
- Conditions
- Diarrhea, HIV Infections
- Keywords
- Diarrhea, Acquired Immunodeficiency Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Shaman PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy, safety, and durability of response of SP-303 in decreasing stool weight in AIDS patients with diarrhea over 6 days of treatment.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV infection meeting CDC criteria for AIDS.
- History of diarrhea for greater than or equal to 14 days prior to screening period (Day 1).
- On stable medical regimen.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crofelemer | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Crofelemer in people with Diarrhea and HIV Infections, run by Shaman Pharmaceuticals at 36 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.