Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs

Chapter 3

AIDS Clinical Trials Group (ACTG)

Janet W. Andersen

3.1 Introduction

This article provides a brief overview of HIV and AIDS, a short history of the founding of the ACTG, an overview of the structure of the ACTG, and sections that outline the major areas covered by the agenda of the ACTG, including clinical trial design issues that developed in the context of the studies and science that was developed to answer this agenda. The ACTG website (www.aactg.org) provides brief overviews of Group studies open to enrollment, information about the ACTG and clinical trials in general, and links to a vast array of sites with information about HIV and AIDS.

3.2 A Brief Primer on HIV/AIDS

Acquired immunodeficiency syndrome (AIDS) is a collapse of the immune system caused by infection with the human immunodeficiency virus (HIV). HIV is a retrovirus; a retrovirus is a virus whose genetic material is RNA that is read into DNA (or reverse transcribed to DNA) when the virus enters the target cell. This DNA incorporates itself into the DNA in the host cell’s nucleus, and then it is replicated to produce new retrovirus particles. HIV is passed from person to person primarily by direct blood transfer from transfusions or needles, by unprotected sexual activity, or from a mother to her child at birth or through breast-feeding. HIV’s target cell in humans is the CD4 or helper T-cell. CD4 cells are the part of the blood’s lymphocytes or white blood cells that are responsible for organizing and ...