Abstract
Poor nutritional status is common among human immunodeficiency virus (HIV)-infected patients including vitamin D (vitD3) deficiency. We conducted a double-blinded, randomized, and placebo-controlled trial in Addis Ababa, Ethiopia, to investigate if daily nutritional supplementation with vitD3 (5000 IU) and phenylbutyrate (PBA, 2 × 500 mg) could mediate beneficial effects in treatment-naïve 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)D3 levels in plasma. Baseline characteristics were detectable viral loads (median 7897 copies/mL), low CD4+ (median 410 cells/µL), and elevated CD8+ (median 930 cells/µL) T cell counts. Most subjects were vitD3 deficient at enrolment, but a gradual and significant improvement of vitD3 status was demonstrated in the vitD3 + 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 vitD3 + PBA for 16 weeks was well-tolerated and effectively improved vitD3 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.
Highlights
Human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) is a key challenge for global health and most of the world’s population living with human immunodeficiency virus (HIV) infection is in Africa.HIV covers multiple stages, from initial and acute infection to chronic infection and further progression to advanced HIV disease or full-blown AIDS
It is well-established that HIV is associated with a massive depletion of CD4+ T helper cells, in the gut [6], but without antiretroviral therapy (ART), CD4+ T cell counts decline in the peripheral blood
Nutritional supplements such as vitamin D3 and phenylbutyrate (PBA), possess pleiotropic immunomodulatory functions that could improve innate mucosal immunity and simultaneously prevent chronic immune activation and dysregulation caused by adaptive immunity [12]
Summary
Human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) is a key challenge for global health and most of the world’s population living with HIV infection is in Africa. The majority of untreated HIV-infected individuals experience intermediate disease progression characterized by a decline in CD4+ T cells counts and a concomitant increase in HIV viral load over time [1,2]. The immune system is under great stress and a balanced diet including a variety of nutrients can strengthen immunity and maintain body weight [11] Nutritional supplements such as vitamin D3 (vitD3 ) and phenylbutyrate (PBA), possess pleiotropic immunomodulatory functions that could improve innate mucosal immunity and simultaneously prevent chronic immune activation and dysregulation caused by adaptive immunity [12]. We performed a double-blind, randomized and placebo-controlled trial in Ethiopia At the time this clinical trial was conducted, the national guidelines in Ethiopia were to initiate ART in HIV patients with clinical symptoms and a CD4+ T cell count
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