This was a non-randomized, non-controlled nutrition intervention study in which
HIV-infected adult patients were recruited from the outpatient clinic of a reference center for
infectious and parasitic diseases (Centro de Referência de Infecções Parasitárias Orestes
Diniz of the Universidade Federal de Minas Gerais, Brazil), between October 2005 and
December 2006. Inclusion criteria were: HIV-positive individuals as confirmed by
polymerase chain reaction; age ≥ 18 years old; patients who have been receiving ARV drugs
at the same dose for a minimum period of 3 months prior to admission. Exclusion criteria were: metabolic disorders such as hyperlipidemia and diabetes mellitus; presence of
lipodystrophy prior to the diagnosis of HIV infection; use of glucocorticoids or any other
steroids, growth hormone, beta-blockers, thiazide or any drugs associated with metabolic
abnormalities and body fat redistribution; any relevant clinical event at the time of enrollment
to the study; pregnancy or breastfeeding; abnormal liver function tests; abnormal renal
function; abnormal thyroid function; reported or proven history of alcohol or drug abuse;
psychiatric conditions; patients who had interrupted the use of ARV drugs; patients who had
attended only the first nutritional counseling session; refusal of the patient to participate.
All selected patients received detailed information about all steps of the study and
signed a written informed consent form. The study was approved by the ethics committee and
has been performed in accordance with the ethical standards laid down in the 1964
Declaration of Helsinki.
During the routine medical evaluation in the referral center 469 HIV-infected
individuals were recruited, according to the order of arrival. Only 98 patients fulfilled the
inclusion criteria and signed the informed consent form. Forty-one patients were excluded
because they had attended only the first nutritional counseling session