A double-blind, placebo-controlled, parallel-group, multi-center study to investigate the effect of Omacor? (n-3 PUFA) on lipid parameters in HIV infected patients treated with HAART

Phase 1

• Conditions: HAART-induced hypertriglyeridemia in HIV infected subjects; MedDRA version: 9.1 Level: LLT Classification code 10020869 Term: Hypertriglyceridaemia

• Registration Number: EUCTR2007-001921-86-GB
• Lead Sponsor: Solvay Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-03
• Study Completion: 2008-12-18
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 65

Inclusion Criteria

1. Subjects = 18 years of age
2. Documented HIV-infection
3. On HAART for the last 3 months
4. Written informed consent
5. Plasma triglycerides values between 200 mg/100 ml and 1000 mg/100 ml
6. Fibrate treatment that has been ongoing for at least 3 months prior to randomization is considered acceptable

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Age below 18 years
2. Other malign disease
3. Subjects assessed to be not compliant with study
4. Females must be non-lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal-ligation or at least one year postmenopausal) or if of childbearing potential, agree to practice effective barrier contraceptive methods, use an intrauterine device (IUD) or use birth-control pills or equivalent injectable contraceptive. The subjects must have been practicing the selected method of birth control for at least 3 months prior to visit 1.
5. Subjects taking fish oil capsules 8 weeks prior to inclusion in this study
6. Known allergy to fish oil or soy
7. Treatment with statins which can not be stopped
8. Treatment with oral anti-coagulants
9. Subjects with an increase risk of bleeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified