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

Bausch Health

Status and phase: Completed; Phase 3

Conditions: HIV Associated Diarrhea

Treatments: Drug: Crofelemer 500 mg; Drug: Crofelemer 125 mg; Drug: Crofelemer 250 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00547898

NP303-101

Details and patient eligibility

About

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.

Enrollment: 374 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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374 participants in 4 patient groups

Placebo

Experimental group

Treatment:

Drug: Placebo

Crofelemer 125 mg

Experimental group

Treatment:

Drug: Crofelemer 125 mg

Crofelemer 250 mg

Experimental group

Treatment:

Drug: Crofelemer 250 mg

Crofelemer 500 mg

Experimental group

Treatment:

Drug: Crofelemer 500 mg