Trial record 10 of 30 for:    " October 23, 2013":" November 22, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Effect of DHA on Lipid and Carbohydrate Metabolism Alterations and Body Fat Distribution in HIV Patients Under HAART.

This study has been completed.
Sponsor:
Collaborators:
Hospital Clinic of Barcelona
University of Barcelona
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT02005900
First received: November 8, 2013
Last updated: December 4, 2013
Last verified: October 2013
  Purpose

Highly active antiretroviral therapy (HAART) is able to cause lipid metabolism and glucose homeostasis alterations, which are associated to the redistribution of body fat. Alterations in lipid and carbohydrate metabolism contribute to the development of a highly atherogenic profile, which together with altered fibrinolysis markers and increased presence of proinflammatory cytokines in blood (especially tumor necrosis factor alpha) that comes associated to the success of HAART can cause the development of accelerated atherosclerosis. Docosahexaenoic acid (DHA) is a polyunsaturated fatty acid that has demonstrated its ability to reduce triglyceride levels; modify cholesterol fractions and increase the size of LDL particles thereby configuring less atherogenic plasma profile. Additionally, administration of DHA has shown antiinflammatory and hypotensive activity, which contributes to reduce the risk of cardiovascular complications in these patients. At a molecular level, DHA acts as a stimulator of the nuclear receptor PPAR-gamma, which has been described to induce an increase in adipocyte differentiation. Furthermore, the anti-inflammatory effects induced by DHA, can decrease the elevated levels of TNF-alpha, which has been implicated in the pathogenesis of body fat redistribution in HIV infected patients undergoing HAART. Therefore, the hypothesis of this project is that DHA will be able to produce lipid-lowering, anti-inflammatory, hypotensive and profibrinolytic effects, which all together should improve atherogenic profile of patients with HIV-1 infection receiving HAART. In addition, their proprieties as PPAR agonist can improve the redistribution of body fat present in many of these patients. The study of the activity of DHA on dendritic cells and monocytes should indicate the absence of immunosuppressive effect of DHA in the context of HIV-1 infection.

In summary, DHA is a natural product, from the omega 3 polyunsaturated fatty acids, the therapeutic properties of which have been described in recent years and has shown cardio-vascular and metabolic beneficial effects, without recognized side effects. The highly purified DHA administration at high doses could be able to reverse, at least partially, lipid abnormalities associated with HAART and to exert a beneficial effect on fat redistribution in HIV-infected patients treated with HAART. To ensure non deleterious immunological treat in these sensitive poly-medicated patients, substantial changes in the functionality of dendritic cells and monocytic will be studied.


Condition Intervention Phase
HIV-associated Hypertriglyceridemia
HIV-associated Hypercholesterolemia
HIV-associated Inflammatory State
Drug: Docosahexaenoic acid (DHA) administration to modulate Triglycerides in HIV patients under HAART
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Placebo-controlled, Randomized 48 Weeks of Duration Study. The Effect of the Administration of Docosahexaenoic Acid on Lipid and Carbohydrate Metabolism Alterations and Body Fat Distribution in Patients With HIV Infection Under High Activity Antiretroviral Treatment

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • Triglyceride level [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Fasting Serum triglyceride level


Secondary Outcome Measures:
  • Fasting Serum total cholesterol level [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Fasting Serum total cholesterol level


Other Outcome Measures:
  • Lipid profile [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Fasting serum levels of LDL, HDL, and non-HDL cholesterol

  • Inflammatory Cytokines [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    TNF alpha, MCP-1, IL-1, and IL-6


Enrollment: 66
Study Start Date: June 2011
Study Completion Date: October 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DHA
Docosahexaenoic acid (DHA) administration to modulate Triglycerides in HIV patients under HAART
Drug: Docosahexaenoic acid (DHA) administration to modulate Triglycerides in HIV patients under HAART
Multicenter, prospective, double-blind, randomized study of 48 weeks duration, in which the effect of 4 g daily of DHA vs 4 g daily of placebo (oleic acid) are studied on modulation of the Triglycerides and other lipids in patients with HIV infection under HAART treatment.
Placebo Comparator: PLACEBO

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Serologic evidence of HIV-1.
  2. Plasma triglycerides > 2.26 mmol/L (200 mg/dL) and/or Total Cholesterol > 6 mmol/L (232 mg/dL) measured after a fasting period of at least 12 hours and confirmed by at least two measures separated by at least an interval of one week.
  3. Body mass index between 25 and 30 kg/m2.
  4. Absence NSAIDs, antihypertensive drugs, lipid-lowering drugs treatments or any other medication known to affect plasma lipid levels.
  5. Alcohol intake <20 g/day.
  6. Absence of Diabetes mellitus and obesity (BMI > 30)
  7. Absence of heart and liver pathologies (within 3 months prior the study).
  8. Absence of renal failure (serum creatinine > 130 mmol/L) or Cr.Cl. < 60 ml/min /1.73 m2.

Exclusion Criteria:

  1. Pregnancy or absence of adequate contraception in childbearing age women.
  2. Presence or fail to fulfil one or more of the conditions listed in paragraphs 2-8 of the inclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005900

Locations
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Hospital Clinic of Barcelona
University of Barcelona
Investigators
Principal Investigator: Pere Domingo, PhD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  More Information

No publications provided

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02005900     History of Changes
Other Study ID Numbers: HSP/DHA/2010
Study First Received: November 8, 2013
Last Updated: December 4, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
DHA
Omega 3
Polyunsaturated Fatty Acids
Dyslipidemia induced by HAART
Lipid metabolic alterations
HIV

Additional relevant MeSH terms:
Hypercholesterolemia
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 21, 2014