Conditions: HIV Associated Diarrhea
Keywords: HIV AIDS Diarrhea HIV Associated Diarrhea
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 374
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Crofelemer 125 mg intervention 2: Crofelemer 250 mg intervention 3: Crofelemer 500 mg intervention 4: Placebo
Intervention descriptions: intervention 1: Crofelemer 125 mg intervention 2: Crofelemer 250 mg intervention 3: Crofelemer 500 mg intervention 4: Placebo

Protocol document: