AEGiS-ATN: AIDS Diarrhea: Phase III Trial Recruiting in Over 30 U.S. Sites

Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.

AIDS Diarrhea: Phase III Trial Recruiting in Over 30 U.S. Sites

AIDS TREATMENT NEWS Issue #299, July 17, 1998
John S. James

Persons with AIDS who have diarrhea (from any cause, including side effects of other drugs) which has lasted 14 days or more may be eligible for a study of PROVIR(TM) (SP- 303), an experimental drug derived from a plant long used in South America to treat diarrhea. This drug, being developed by Shaman Pharmaceuticals, is believed to work differently than diarrhea medicines in common use, to directly reduce abnormal flow of water into the intestines.

This study requires six days of inpatient treatment, followed by 21 days of outpatient treatment for those who respond to the drug. Three quarters of the volunteers will receive the active drug in various doses and formulations; one quarter will receive a placebo.

Volunteers must be at least 18, meet the criteria for AIDS and be on a stable antiviral regimen, have a stool weight of at least 300 grams per day, and not be pregnant or lactating. They must not have been in a trial of another experimental drug within 30 days, nor received treatment for an intestinal infection within 14 days. There are some additional medical criteria.

Shaman Pharmaceuticals, Inc., of South San Francisco, works with traditional healers to discover drugs in plants that already are in human use--giving it a better success rate in drug discovery than other companies which screen plants at random. Unlike some companies, Shaman does not try to patent the plants themselves--and it takes steps to return value to the communities from which its discoveries are derived. It is also testing an oral drug for systemic fungal infection, and several potential treatments for type II diabetes.

Research sites are located in the following area: Arizona (Phoenix, Scottsdale); California (Los Angeles, Palo Alto, San Francisco, West Hollywood); District of Columbia; Florida (Coral Gables, Maitland, Miami, Orlando, Tampa); Georgia (Atlanta, Decatur); Illinois (Oak Park); Indiana (Indianapolis); Louisiana (Kenner, New Orleans); Massachusetts (Boston); Maryland (Baltimore); Minnesota (Minneapolis, St. Paul); Michigan (Detroit); Missouri (St. Louis); North Carolina (Raleigh); New Jersey (Union); New York (Brooklyn, New York City); Puerto Rico (Ponce, San Juan); Texas (Houston, San Antonio); Washington (Seattle).

For more information about the PROVIR diarrhea trial, call NCGS & Associates, 843-723-9555.

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