Creon in HIV Patients With Steatorrhea

• Status: Terminated
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The study investigates the effect of pancreatic enzymes on steatorrhea in HIV patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Pancreatin; Pancrelipase

Criteria

Inclusion Criteria HIV positive patients with clinically stable disease (Karnofsky Performance Status > 40);

• Steatocrit > 2 %;

• Females of child-bearing potential must have a negative pregnancy test during prestudy or the subject must be surgically sterile or be at least 1 year postmenopausal as judged by the investigator;

• Women of child-bearing potential must be using a medically acceptable method of birth control throughout the study

Exclusion Criteria

• Known allergy to pancreatin or any history of abnormal drug reaction;

• Known diagnosis of pancreatic exocrine insufficiency due to e.g. chronic pancreatitis or cystic fibrosis or pancreatectomy;

• Intake of an experimental drug within four weeks prior to entry into the study;

• Alcohol abuse within the last six months;

• Suspected non-compliance or non-cooperation;

• Any other lack of fitness, in the investigator's opinion, to participate in or to complete the study;

• Patients with a stool fat excretion <= 7 g/day according to van de Kamer during the run-in period