TI    Concorde Trial
 AU    National Institute of Allergy and Infectious Diseases, National 
       Institutes of Health 
 SO    NIAID Update
 TX    In a letter in the April 3 Lancet, investigators report initial
       results of a joint Anglo-French study, the Concorde trial, that
       assessed the benefits of the drug zidovudine (AZT) in HIV- infected
       individuals without symptoms. The authors report that after three
       years of follow-up, they saw no differences in the cumulative risk
       of death or disease progression between HIV- infected individuals
       given immediate AZT therapy and those who were not treated until they
       developed decreases in the numbers of certain immune system cells or
       at the time that AIDS-related symptoms occurred.

       Daniel F. Hoth, M.D., director of the Division of AIDS at the
       National Institute of Allergy and Infectious Diseases (NIAID), says,
       "The Lancet letter is based on a preliminary analysis, with many
       important details to be clarified. We look forward to meeting with
       our European colleagues and reviewing this data in detail. However,
       at this time we see no basis for changing the current recommendation
       to initiate antiretroviral therapy for HIV-infected persons whose
       CD4+ T cell count falls below 500 per cubic millimeter(mm3) of
       blood." CD4+ T cells are the crucial immune system cells depleted
       during HIV infection. A healthy, uninfected individual usually has
       800 to 1200 CD4+ T cells/mm3.

       The Lancet authors report that while their findings are "not
       inconsistent" with findings of previous studies at comparable
       follow-up times, the delay in progression to AIDS or ARC seen in
       previous studies "was not seen over the longer follow-up period."

       Four previously-published placebo-controlled trials, with a median
       follow-up period of one year, have found that early treatment with
       AZT in certain patients with early or no HIV-related symptoms can
       delay the onset of severe disease. The largest of these, the
       NIAID-sponsored AIDS Clinical Trials Group (ACTG) 019, found that AZT
       delayed the onset of advanced AIDS related complex (ARC) and AIDS for
       individuals who entered the study with CD4+ T cell counts of 500/mm3
       or less.

       Paul Volberding, M.D., principal investigator of ACTG 019 and
       director of the AIDS Program at San Francisco General Hospital, says,
       "It is increasingly apparent AZT is a drug with benefits that are
       limited in duration, particularly in patients with more advanced
       disease. While we know that AZT can help patients in the short term,
       the real focus of AIDS clinical research today is on developing other
       treatment strategies, such as sequential or combination therapies,
       that are effective and well-tolerated over extended periods of time."

       A state-of-the-art conference on the optimal use of antiretrovirals,
       sponsored by NIAID, will be held this summer in Bethesda, MD.

       Prepared by:

       The Office of Communications
       NIAID, NIH
       Bethesda, MD 20892

       Public Health Service
       U.S. Department of Health and Human Services
 DE    Concorde trial. AZT. Disease progression. Drug therapy. ACTG. 
       Clinical trial results. Efficacy. HIV infection.
 CD    931005

 * Origin: AEGIS/San Juan Capistrano 714.248.2836 (CASAN)  (1:103/927)
 * Provided as a service of THE BACKROOM - NYC * 718-951-8256