Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea

Completed · Phase 3 · Has a placebo group

Conditions studied: HIV Associated Diarrhea

In brief

This is a randomized, double-blind, parallel-group, placebo-controlled, multi-center study. This study will compare an investigational new drug (crofelemer) to placebo for the control of HIV-associated diarrhea. The first stage of the study will determine the optimal dose of study drug based on safety and response to therapy and the second stage will evaluate further the effectiveness of the optimal dose.

Key facts

Study ID

NCT00547898

Run by

Bausch Health Americas, Inc.

People needed

374

Starts

2007-10-01

Expected to finish

2011-07-11

Last updated by the study team

2020-09-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of HIV-1 infection confirmed by standard serological tests
• Stable medical regimen for treatment of HIV disease and associated conditions for at least 4 weeks prior to screening
• Patient-reported history of diarrhea, defined as either persistently loose stools despite regular ADM use, or one or more watery bowel movements per day without regular ADM use, of at least 1 month duration
• Colonoscopy within the past 5 years if ≥ 50 years of age.

You may not qualify if…

• Pregnancy or breast-feeding
• Current or past gastrointestinal (GI) medical or surgical conditions
• Use of certain opiate pain medication within 2 weeks of screening
• Use of an antibiotic within 2 weeks prior to screening, with the exception of stable antibiotic therapy for prophylactic treatment of infection or an HIV-associated condition
• CD4 counts < 100 cells/mm3
• Previous randomization into this study, or into any other crofelemer study

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Bakersfield, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Oakland, California, United States
• Study site — Palm Springs, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — San Mateo, California, United States
• Study site — Denver, Colorado, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Ft. Pierce, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.