Status:
TERMINATED
Creon in HIV Patients With Steatorrhea
Lead Sponsor:
Abbott
Conditions:
Steatorrhea
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The study investigates the effect of pancreatic enzymes on steatorrhea in HIV patients.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00623025
Start Date
January 1 2009
End Date
August 1 2009
Last Update
August 1 2011
Active Locations (2)
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1
Site Reference ID/Investigator# 59364
Bucharest, Romania, 021105
2
Site Reference ID/Investigator# 59363
Craiova, Romania, 200515