THE EFFECT OF SUPPLEMENTAL BETA-CAROTENE ON IMMUNOLOGICAL INDEXES IN PATIENTS WITH AIDS - A PILOT-STUDY

Patients with the acquired immunodeficiency syndrome (AIDS) are charac terized by a decrease in the number of T helper cells, a defect that i s linked to the impaired immunologic competence. Vitamin A and its die tary precursor, betacarotene, increase absolute T helper cell counts a s well as indices of T cell function in both human and animal models. To determine if short-term beta-carotene treatment affects T lymphocyt e subsets in patients with AIDS, a single-blind, non-randomized clinic al trial of beta-carotene was performed in seven patients with AIDS. E nrollment criteria included no evidence of: a) active opportunistic in fection; b) greater than 1 kilogram change in weight in the month prec eding enrollment; c) chronic diarrhea or malabsorption; and d) hepatic disease or significant anemia. Beta-carotene was given with meals in two divided doses of 60 mg/day for four weeks; this was followed by no therapy for six weeks. Samples for total white blood cell, lymphocyte and T lymphocyte subset counts were measured at baseline, at the end of four weeks of treatment and another six weeks after treatment had s topped. P24 antigen, beta-2 microglobulin and liver function tests wer e also measured. All subjects tolerated the treatment well without evi dence of toxicity. In response to beta-carotene, total lymphocyte coun ts rose by 66 percent (.05 < p <.10), and CD4+ cells rose slightly, bu t insignificantly, in the entire group. In all three of the patients w ho had baseline CD4+ cells greater than 10/mu l, however, the mean abs olute increase in CD4+ cells in response to beta-carotene was 53 +/- 1 0 cells/mu l (p <.01). Six weeks off beta-carotene treatment, the abso lute CD4+ cell count returned to pretreatment levels (p <.01). No chan ge was observed in CD8+ cells. P24 antigen and beta-2 microglobulin di d not change during treatment. These preliminary observations suggest that short-term treatment with beta-carotene may increase CD4+ cell co unts in patients with AIDS who have greater than 10 cells/mu l.