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1993.04.05 :  Grant -- Effectiveness of AZT, ddI

Contact: Bob Isquith (301) 227-8364 ext. 159
April 5, 1993

     The U.S. Public Health Service's Agency for Health Care
Policy and Research today announced a $2.1 million five-year
grant to the Johns Hopkins University to evaluate the
effectiveness and appropriate use of AZT, ddI and other drugs
used in treating HIV-related illnesses, including AIDS.
     The award is the first of several that AHCPR will make to
study the effect on patient outcomes of pharmaceuticals for
treating a wide variety of diseases and conditions.
     HHS Secretary Donna E. Shalala said, "While drugs have been
reviewed for basic safety and effectiveness before they go on the
market, these further studies should help physicians make the
best treatment choices."
     Under terms of the grant, researchers will determine the
effectiveness of antiretrovirals -- drugs that destroy or inhibit
growth of HIV and related viruses, and that are widely used to
delay or prevent the progression of HIV disease (e.g., AZT and
ddI).  The researchers also will study the effectiveness of
antibiotics, including trimethoprim, sulfamethoxazole and others,
commonly used to treat "opportunistic" infections that often
develop as a result of AIDS patients' weakened immune systems.
     J. Jarrett Clinton, M.D., administrator of AHCPR, said the
award to Johns Hopkins University adds a new element to AHCPR's
patient outcomes research program, which is examining the
relative effectiveness of methods to diagnose, treat, manage and
prevent a wide range of diseases to determine which work best and
for whom.
     The study will be directed by Richard E. Chaisson, M.D.,
assistant professor at the Johns Hopkins School of Medicine.
     "Patient outcomes research examines how different medical
treatments affect the outcomes of care.  It looks at medicine as
it's practiced," Dr. Clinton said.  He noted that as new drug
therapies for HIV disease come into use, data regarding their
appropriateness and effectiveness in treating patients are often
incomplete.
     Although work under the grant will continue over five years,
interim results are expected to be published during this period. 
The researchers will use a large database they will develop,
documenting the response to drug therapies of approximately 3,000
individuals who are infected with HIV.
     Researchers want to determine whether "surrogate laboratory
markers," or specialized laboratory tests of patients' blood or
tissues -- for example, CD4 lymphocyte (white blood cell)
counts -- are influenced by specific drug therapies, and whether
these can be correlated with favorable clinical results or
outcomes.  Identification of such "markers" can potentially help
clinicians select the most effective drug to use against
infection in individual patients.
     Other AIDS research supported by AHCPR examines quality and
cost of care and financing issues.  ###