Guide to major clinical trials of antiretroviral therapy in human immunodeficiency virus-infected patients: protease inhibitors, non-nucleoside reverse transcriptase inhibitors, and nucleotide reverse transcriptase inhibitors.

Abstract

In this AIDS Commentary, Drs. Tavel, Miller, and Masur of the National Institutes of Health present this compilation of clinical trials of antiretroviral therapy in HIV-infected patients, which complements two similar reviews published as AIDS Commentaries in Clinical Infectious Diseases (1995;20:1145–51 and 1996;23:15–27). Whereas the previous compilations focused on trials of nucleoside analogues, this review is based on published articles and abstracts of clinical trials of protease inhibitors, non-nucleoside reverse transcriptase inhibitors, and nucleotide reverse transcriptase inhibitors in HIV-infected patients. The intent is to present a thorough, but not necessarily exhaustive, review of studies that have shaped our principles of antiretroviral therapy. Preference is given to clinical endpoint trials, proof-of-concept trials that have influenced the standard of care for HIV treatment, double-blind, randomized trials, and large trials with long-term patient followup. Smaller trials that address important questions are also included.