drugset / Trial / NCT00547898
Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2007-10
- Primary completion
- 2011-01-27
- Completion
- 2011-07-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Crofelemer | Small molecule | 125 mg | Oral |
| Subject | Crofelemer | Small molecule | 250 mg | Oral |
| Subject | Crofelemer | Small molecule | 500 mg | Oral |