FDA Antiviral Drugs Advisory Committee met earlier this month (November 6-8, 1995) to review approval applications for Roche's protease inhibitor saquinavir (trade name Invirase ), Glaxo-Wellcome's 3TC (lamivudine, trade name Epivir ) and Bristol's d4T (stavudine, trade name Zerit )…
Community Envoy to Food and Drug Panel Urges Caution in Approving New Anti-HIV Therapueutics and in Providing Early Access "Badgering, hijacking activists" The FDA recently convened hearings regarding its Accelerated Approval program and the future use of changes in plasma…
Despite Pressure to Crown Combo King, 175 Investigators Soft-Pedal Combination Nucleoside Study's Startling Findings The Didanosine Surprise Even skeptics can find something to enjoy in the surprising results of AIDS Clinical Trials Group (ACTG) protocol #175. Last month's TAGline ("Combo…
In September, the Senate Appropriations Committee voted to maintain a consolidated appropriation for NIH AIDS research, sparing the Office of AIDS Research from becoming a paper tiger at the start of the next fiscal year. The Senate Committee's actions, however,…
ACTG 175 confirms the benefit of antiretroviral therapy in persons starting between 200-500 CD4 cells and before the development of AIDS (cf. ACTG 016, 109). ACTG 175 shows for the first time that initiating antiretroviral therapy at this time (CD4…
House Republican Plan Calls for AIDS Research Dollars to Be Mixed Into Pot For All to Avail Themselves Of The OAR as paper tiger In 1993, dozens of AIDS organizations and hundreds of AIDS researchers joined together to push for…
Controversial Nucleoside Study Awakens To A World Strangely Disaffected By Its Prepackaged Proclamation Beware the Composite Endpoint "Endlessly scrutinizing mediocrity" is how the 3,000 patient combination-versus- monotherapy mega-trial ACTG 175 was characterized in a July 29, 1991 issue of ACT…
Feel Good Merck Meeting Leaves Everybody Agreeing, But Brazil Study Bodes Ill for the Future On June 23 1995, members of TAG met with statisticians from Merck and outside statistical experts to discuss the methodological assumptions of its Phase III…
New Model of Immune Defense to HIV Shows How Nature of Response Might Determine Eventual Outcome Sloppy RT, Bane of All A provocative research paper initially published in the international weekly science journal Nature ("Antigenic oscillations and shifting immunodominance in…
With Two Down And Integrase On Deck, AIDS Research Team Hopes For a Hit--Or Will It Be 'Three Up, Three Down?' Third and Final Enzymatic Target The HIV genome encodes for three enzymes that are necessary for infection and replication…