Effect of #Zinc Supplementation vs Placebo on Mortality Risk and #HIV Disease Progression Among HIV-Positive Adults With Heavy #Alcohol Use

.. A total of 254 participants (184 men [72%]; mean [SD] age, 34 [6] years) were enrolled in the trial; 126 were randomized to receive zinc, and 128 were randomized to receive placebo. Participants had high CD4 cell counts (mean [SD], 521 [292] cells/mm3), and 188 (74%) reported heavy drinking in the past week. In the main analyses, zinc supplementation did not affect changes in the VACS Index score at 18 months (change for zinc, mean [SD], 0.49 [14.6]; median [interquartile range], 0.0 [−7.0 to 6.0]; change for placebo, mean [SD], 5.5 [17.2]; median [interquartile range], 6.0 [−6.0 to 14.0]; adjusted mean difference [AMD], −4.68; 95% CI, −9.62 to 0.25; P = .06) or any secondary outcomes, including change in CD4 cell count (AMD, 41.8 cells/mm3; 95% CI, −20.3 to 103.8 cells/mm3; P = .19),

Reynolds Risk Score (AMD, −0.014; 95% CI, −0.167 to 0.139; P = .85), interleukin-6 level (AMD, −0.13 pg/mL; 95% CI, −0.38 to 0.11 pg/mL; P = .30), dimerized plasmin fragment D level (AMD, −0.21 μg/mL fibrinogen equivalent units; 95% CI, −0.48 to 0.07 μg/mL fibrinogen equivalent units; P = .14), soluble CD14 level (AMD, −38.01 ng/mL; 95% CI, −166.90 to 90.88 ng/mL; P = .56), intestinal fatty acid binding protein level (AMD, 0.08 pg/mL; 95% CI, −0.07 to 0.22 pg/mL; P = .32), and lipopolysaccharide binding protein level (AMD, −0.09 ng/mL; 95% CI, −0.23 to 0.06 ng/mL; P = .24). In the per-protocol analyses, zinc supplementation statistically significantly affected changes in the VACS Index score at 18 months (AMD, −7.49; 95% CI, −13.74 to −1.23; P = .02); however, the adherence rate to zinc supplementation was 51%.

Conclusions and Relevance Zinc supplementation did not reduce mortality risk, CD4 cell counts, cardiovascular disease risk, and levels of inflammation or microbial translocation in people with heavy alcohol use who are living with HIV/AIDS. Zinc supplementation did not change the VACS Index score but may have been limited by low adherence.

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