Scientific and Regulatory Issues in the Era of Antiretrovirai Polytherapy and a Viral Load-Driven Standard of Care (Version 0.5) A Report to the FDA Antiviral Drugs Advisory Committee 14 July 1997 by Spencer Cox, Paul Dietz, Mark Harrington & Theo…
ACTG 320 Proves that Indinavir and 3TC, when Added to AZT, Reduce AIDS and Death by Half when Compared with AZT and 3TC without Indinavir in HIV-Positive Individuals with Fewer than 200 CD4 Cells and Over Three Months of AZT…
A Report from the 11th International Conference on AIDS Vancouver, British Columbia, 8-11 July 1996 By Mark Harrington From the Introduction The year 1996 has brought a sea change in AIDS research and treatment. Three major factors have contributed to…
From 1996 by Mark Harrington After Berlin, no one could credibly believe that AIDS drug development was on track. Indeed, it looked likely that the various initiatives AIDS activists had worked with FDA, NIH and industry to develop were actually…
Current Issues in Research and Treatment of HIV-Associated Wasting and Malnutrition by Tim Horn & David Pieribone July 1996 From the Introduction Wasting syndrome can be a chronic and deadly manifestation of HIV. Multiple studies demonstrate that progressive weight loss…
by Mark Harrington 7 November 1995 In September, 1994, the Treatment Action Group spelled out the following conditions as necessary for our support of an accelerated NDA for an HIV protease inhibitor: Adequate and well-controlled clinical endpoints studies are well…
AIDS Research Highlights from the 35th Interscience Conference on Antimicrobial Agents & Chemotherapy (ICAAC) September 1995 by Mark Harrington and Michael Marco with Spencer Cox and Tim Horn From the Introduction The 35th ICAAC was a more interesting conference than…
August 1995 By Spencer Cox Edited by Mark Harrington & Bruce Schackman From the Executive Summary Over the period in which FDA has reviewed and regulated anti-HIV therapies, there has been a substantial decline in the quality and quantity of…