Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

Bausch Health

Status and phase: Completed; Phase 3

Conditions: Diarrhea With HIV; HIV Enteropathy

Treatments: Drug: Crofelemer

Study type: Interventional

Funder types: Industry

Identifiers

NCT01374490

CFHD3092

Details and patient eligibility

About

This study is being conducted to evaluate the safety and tolerability of crofelemer 125 mg twice a day, taken orally, over 48 weeks of therapy in human immunodeficiency virus-positive (HIV+) subjects with diarrhea.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female ≥ 18 years old
• History of HIV-1 infection
• On an antiretroviral therapeutic regimen for treatment of HIV-1 disease and associated conditions (including prophylactic antibiotics for Pneumocystis jirovecii or infection) for at least 4 weeks prior to screening
• Self-reported presence of diarrhea necessitating ADM use for at least 4 weeks

Exclusion criteria

• CD4 counts < 100 cells/mm3
• Oral temperature greater than 38.0° C, or unintentional weight loss of 5.0 kg or greater during the prior 2 months
• Bright red blood per rectum judged not to be of an anal (e.g., hemorrhoid, fissure) origin
• Immediate need for GI surgery or intervention for active GI bleeding, pancreatitis, peritonitis, intestinal obstruction, or intra-abdominal abscess

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Crofelemer

Experimental group

Treatment:

Drug: Crofelemer