Daily Nutritional Supplementation with Vitamin D₃ and Phenylbutyrate to Treatment-Naïve HIV Patients Tested in a Randomized Placebo-Controlled Trial.

Poor nutritional status is common among human immunodeficiency virus (HIV)-infected patients including vitamin D (vitD(3)) deficiency. We conducted a double-blinded, randomized, and placebo-controlled trial in Addis Ababa, Ethiopia, to investigate if daily nutritional supplementation with vitD(3) (5000 IU) and phenylbutyrate (PBA, 2 x 500 mg) could mediate beneficial effects in treatment-naive HIV patients. Primary endpoint: the change in plasma HIV-1 comparing week 0 to 16 using modified intention-to-treat (mITT, n = 197) and per-protocol (n = 173) analyses. Secondary endpoints: longitudinal HIV viral load, T cell counts, body mass index (BMI), middle-upper-arm circumference (MUAC), and 25(OH)D-3 levels in plasma. Baseline characteristics were detectable viral loads (median 7897 copies/mL), low CD4(+) (median 410 cells/mu L), and elevated CD8(+) (median 930 cells/mu L) T cell counts. Most subjects were vitD(3) deficient at enrolment, but a gradual and significant improvement of vitD(3) status was demonstrated in the vitD(3) + PBA group compared with placebo (p < 0.0001) from week 0 to 16 (median 37.5 versus 115.5 nmol/L). No significant changes in HIV viral load, CD4(+) or CD8(+) T cell counts, BMI or MUAC could be detected. Clinical adverse events were similar in both groups. Daily vitD(3) + PBA for 16 weeks was well-tolerated and effectively improved vitD(3) status but did not reduce viral load, restore peripheral T cell counts or improve BMI or MUAC in HIV patients with slow progressive disease. Clinicaltrials.gov NCT01702974.