Improvement in immune parameters and human immunodeficiency virus‐1 viral response in individuals treated with 16α‐bromoepiandrosterone (HE2000)

ABSTRACT A randomised, double-blind, placebo-controlled study examined the safety, tolerance, immunological effect and anti-human immunodeficiency virus (HIV) activity of sub-cutaneously administered HE2000 (16α-bromoepiandrosterone) as monotherapy in treatment-naive patients with HIV-1. Twenty-four patients received five sequential daily doses of 50 or 100 mg of HE2000 or placebo every 6 weeks for up to three courses, and were followed thereafter for 3 months. HE2000 was safe, with transient injection site reactions being the main side-effect. Peripheral blood samples, collected serially, were analysed for changes in immune cell phenotypes. Significant increases were observed in the numbers of circulating dendritic cells, early activated (CD69 + CD25 – ) CD8 T-cells and T-NK cells after administration of 50-mg doses of HE2000 (p