Deficiency of zinc is prevalent in HAART and non-HAART treated HIV-1 seropositive males and female drug users and has been shown to have a profound impact on HIV disease status. Low levels of zinc are associated with an increased risk for HIV-1 related mortality, while increasing levels of plasma zinc are associated with slower disease progression. Other investigators have reported that zinc administration in HIV/AIDS patients stabilized weight, increased CD4 cell count, and reduced the number of opportunistic infections. As drug users are particularly susceptible to zinc deficiency (56 percent have low serum zinc levels), zinc therapy in HIV-1 infected drug users with low zinc levels (> 0.35 ug/ml and < 0.75ug/ml), is both timely and warranted. Originally the proposal was to randomize 210 participants into the two study arms but the revised application intends to use stratified randomization based on viral load to balance any potential impact of antiretroviral treatment on CD4 cell count and clinical events. The investigators estimate that only 20 percent of the study population will be on newer therapies such as HAART. Zinc supplements will be given at nutritional doses (15 mg for men and 12 mg for women) and compliance to the intervention and safety will be monitored throughout the trial. Clinical and laboratory markers will be assessed at either 3 or 6 month intervals over the 30 month study.
The specific aims will determine if zinc therapy in HIV-1 infected men and women who abuse drugs and have low plasma zinc levels will have higher CD4 cell counts, lower viral loads and prolonged time to events, including AIDS defining opportunistic infections, or AIDS-related death.
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