Current status of clinical trials in HIV disease in Australia

Clinical trials in Australia in diseases related to human immunodeficiency virus (HIV) have steadily expanded from the earliest national study of zidovudine to a range of trials either actively recruiting or being activated that cover a wide spectrum of primary viral, opportunistic infection and opportunistic malignant diseases. From its earliest establishment as the National Health and Medical Research Council special unit to its current role as the clinical trials unit of the National Centre in HIV, this central group has organized a coordinated approach to the conduct of clinical trials that has been a hallmark of Australia's response to the treatment of HIV-related disease. The original local trials were in the form of collaboration in multicenter trials, initiated by the pharmaceutical industry, with the participation of only a few major treatment centers. This has now evolved to a network of more than 20 hospital and ambulatory care centers and a group of enthusiastic and committed general practitioners who have contributed data to a number of major studies. These include the national zidovudine study that generated data on the use of surrogate markers such as CD4 and p24 antigen as predictors of survival, studies of the combination of acyclovir and zidovudine that have indicated a new direction in combination antiretroviral therapy, placebo-controlled studies of zidovudine in asymptomatic individuals that may alter the timing of introduction of therapy, and the MRC/INSERM study of didanosine in advanced disease that will give the clearest indication of its activity yet to be reported.(ABSTRACT TRUNCATED AT 250 WORDS)