Creon in HIV Patients With Steatorrhea

Overview

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

Full Title of Study: “Double-blind, Cross-over, Randomized, Placebo-controlled, Multi-center Study to Investigate the Effect of Creon®25 000 on the Coefficient of Fat Absorption of HIV-infected Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2009

Interventions

  • Drug: Creon 25000
    • 6 to 9 capsules Creon 25000 per day
  • Drug: Placebo
    • 6 to 9 capsules placebo per day

Arms, Groups and Cohorts

  • Experimental: 1
  • Placebo Comparator: 2

Clinical Trial Outcome Measures

Primary Measures

  • Coefficient of fat absorption (CFA)
    • Time Frame: After 2 weeks

Secondary Measures

  • Stool fat excretion
    • Time Frame: After 2 weeks
  • Normalization (yes, no) of stool fat excretion, i.e. < 7 g/day
    • Time Frame: After 2 weeks
  • Response (yes, no) with respect to stool fat excretion, i.e. improvement in stool fat excretion as compared to baseline
    • Time Frame: After 2 weeks
  • Stool weight
    • Time Frame: After 2 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abbott
  • Provider of Information About this Clinical Study
    • Suntje Sander, Director Clinical Development, Abbott
  • Overall Official(s)
    • Suntje Sander, PhD, Study Director, Abbott

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