Study Confirms that Combination Treatment Using a Protease Inhibitor Can Delay HIV Disease Progression and Death

NIH NEWS RELEASE
NATIONAL INSTITUTES OF HEALTH National Institute of Allergy
and Infectious Diseases
FOR RELEASE Pat Randall
Monday, Feb. 24, 1997 [phone]
Study Confirms that Combination Treatment Using a Protease Inhibitor
Can Delay HIV Disease Progression and Death
Research supported by the National Institute of Allergy and Infectious Diseases (NIAID)
has demonstrated that in patients with advanced HIV disease the combination of a protease
inhibitor plus two nucleoside analogue reverse transcriptase inhibitors (RTIs) is significantly
more effective in reducing the occurrence of AIDS-defining illnesses or death than two RTIs
alone. The study, known as ACTG 320, was designed to determine the efficacy and safety of
the protease inhibitor indinavir when given in combination with zidovudine (ZDV) [or stavudine
(d4T)] and lamivudine (3TC), as compared to ZDV (or d4T) plus 3TC.
As a result of recent data showing the dramatic effectiveness of protease inhibitors in
lowering viral burden, strategies using protease inhibitors in combination with other drugs are
being widely used. "The results of ACTG 320 confirm the importance of including protease
inhibitors in treatment strategies for patients with advanced HIV disease," says Anthony S.
Fauci, M.D., NIAID director. "Significantly, the current study provides additional evidence that
combination approaches using protease inhibitors can reduce the risk of death."
Preliminary results of the study were reviewed Feb. 18, 1997, by an independent data
and safety monitoring board, which recommended early termination of enrollment and closure
of the study. They based this recommendation on the significant benefit of the triple
combination including indinavir in delaying disease progression and death.

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