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

Phase 3

Completed

• Conditions: Diarrhea; HIV Infections

• Registration Number: NCT00002408
• Lead Sponsor: Shaman Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 1999-04
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (36)

Hill Top Research Ltd; 🇺🇸 Scottsdale, Arizona, United States

Phoenix Living Ctr; 🇺🇸 Scottsdale, Arizona, United States

UCLA Care Ctr; 🇺🇸 Los Angeles, California, United States

AIDS Research Ctr / Dept of Veterans Affairs; 🇺🇸 Palo Alto, California, United States

San Francisco Gen Hosp; 🇺🇸 San Francisco, California, United States

Lynn House Hospice; 🇺🇸 West Hollywood, California, United States

AIDS Research Alliance; 🇺🇸 West Hollywood, California, United States

Howard Univ; 🇺🇸 Washington, District of Columbia, United States

GCRC; 🇺🇸 Washington, District of Columbia, United States

Community CRI of South Florida; 🇺🇸 Coral Gables, Florida, United States

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