Design of a prospective study of the pulmonary complications of human immunodeficiency virus infection

Because no studies have systematically described the pulmonary complications associated with early stages of infection with the human immunodeficiency virus (HIV), the National Heart, Lung and Blood Institute and the National Institute of Allergy and Infectious Diseases jointly initiated a prospective cohort study in 1987 to describe the incidence and course of lung diseases at all stages of HIV infection. This paper describes the ongoing study and highlights some of its unusual features. Six clinical centers from different geographic areas in the U.S. began enrolling participants in 1988, and the resulting cohort comprises 1353 members. HIV seropositive participants were randomized to “intensive” (pulmonary disease screening and follow-up at 3-month intervals) or “routine” (6-month follow-up intervals with annual screening) follow-up to assess the impact of these strategies on patient outcomes. New information from this complex study will lead to a broader understanding of the pulmonary diseases associated with HIV infection and will have relevance to clinical as well as epidemiologic aspects of HIV disease.