Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea
Status:
Completed
Trial end date:
2011-07-11
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Bausch Health Americas, Inc. Valeant Pharmaceuticals International, Inc.