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

Hypothesis: DHA treatment would be able to revert, at least partially, the lipid disturbances associated with HAART and to improve or at least not to worse fat redistribution associated with HAART, without inducing further derangements to dendritic cells and monocyte functional ability.

Variables: effects of DHA treatment on total cholesterol and its fractions, triglycerides, insulin, fibrinolysis markers, tumor necrosis factor alpha (TNF-α), and fat distribution assessed by anthropometric measurements, bioimpedance, sonography, DEXA and abdominal CT. Effects of DHA administration on phenotype and functional capabilities of dendritic and mononuclear cells. Objective: To determine if treatment with high doses of highly purified docosahexanoic acid (DHA) is able to revert, totally or partly, the lipid disturbances and the fat redistribution associated with highly active antiretroviral therapy (HAART), and the effects on phenotype and function of dendritic cells and monocytes Data analysis: Baseline data will be analyzed for a good balance. Fisher´s exact test will be used to assess differences between categorical variables, Student's t test for continuous variables, and Mann-Whitney test for ordinal variables. The main efficacy variable will be differences between baseline and final values using MANCOVA model taking baseline value as covariable. Efficacy will be assessed by contrasting adjusted means at the end of the study between both groups of treatment. Intention to treat analysis will be used.

The methodology to perform in the centers where the clinical trail will be conducted are the following: After obtaining informed consent, the patient's baseline will be examined with the collection of demographic data, HIV infection status, pharmacological data, anthropometric parameters, and it will proceed to conduct a complementary examination designed to identify and define body fat composition, body fat distribution and to perform a basal analysis including the parameters previously mentioned. It also will be evaluated the hygienic-dietetic habits of the patient with special attention to alcohol intake, physical activity and concomitant medication. This procedure will be carried out by making retrospective diaries from the last 7 days. The patient's daily caloric intake will be quantified by the Nutrilogic ® software (Bio Logic, Barcelona, España). Physical activity will be quantified by the Minnesota scale (Elosua R, Marrugat J, Molina L, Pons S, The MARATHOM Investigators. Validation of the Minnesota leisure time physical activity questionnaire in Spanish men. Am J Epidemiol 1994, 139: 1197-1209).

Body fat composition and body fat distribution: will be done with the following additional tests:

Densitometry or DEXA: Will be determined with the patient in supine position with legs straight and feet together, on a standardized examination table from a densitometry device (Lunar Prodigy, Madison, WI, USA). In the initial study enerarán more faces of the different regions that will be copied and transferred to the images of subsequent studies to reduce the variability of successive determinations. There will be performed a body fat measurement, body composition and assessment of bone mineral density by dual absorptiometry technique. There will be performed a total body "scan" (body composition) or focused on lumbar spine (trabecular bone) and proximal third of the femur (cortical bone) for the evaluation in the last two cases of bone mineral density and a possible osteopenia or osteoporosis.