Table 4.

Proposed outcome measures for future trials of macronutrient supplementation in HIV-infected patients

Parameter	Measure
Mortality	All cause HIV-related
Anthropometric	Weight, body mass index, mid-upper arm circumference, waist & hip circumferences, triceps skinfold thickness
Body composition	Bioelectrical impedance measurement of body cell mass, fat-free mass, fat mass, total body water
Physical findings	Peripheral and pulmonary edema CNS abnormalities Mouth & tongue changes (e.g ulcerations, thrush) Abnormal fat distribution (lipodystrophy)
Symptoms	Constitutional, gastrointestinal, respiratory, cardiovascular, neurologic, psychiatric (i.e. depression)
Functional status	Quality of life Economic productivity
Immunologic	CD4+ lymphocyte count Total lymphocyte count, T-cell helper/suppressor ratio, T-cell response Peripheral eosinophil count Time to ART initiation
Metabolic	Resting metabolic rate
Response to ART	Time to viral suppression Durability of viral suppression “suppressed survival” Incidence of new opportunistic infections
ART tolerance and adherence	Incidence of drug toxicities and side effects Adherence (pill counts and days late to pharmacy) Serum drug levels Incidence of regimen change due to drug intolerance
Dietary	Dietary intake/recall, household food security
Serum markers:	Nutrition status: hemoglobin, albumin,* pre-albumin,* ferritin,* vitamin B12, folic acid, 25-hydroxyvitamin D, vitamin A (retinol) Metabolic processes: phosphate, potassium, magnesium, sodium, serum lipids, hepatic function, fasting insulin Systemic inflammation: C-reactive protein, α-1 acid glycoprotein

^*Acute phase reactants that may be altered as a result of a pro-inflammatory state.