ACTG 315 Preliminary Results: Drug Cocktail Restores Partial Immune Function

In-depth studies of immune function in people with moderately advanced HIV disease who were treated for three months with an antiretroviral drug cocktail show that immunity can be partially restored, according to preliminary results from AIDS Clinical Trials Group (ACTG) 315, supported by the National Institute of Allergy and Infectious Diseases (NIAID). The drug combination being tested consists of zidovudine (AZT), lamivudine (3TC) and the protease inhibitor ritonavir.

Protocol chair Michael M. Lederman, M.D., plans to discuss these interim results in a late-breaker session at the Fourth Conference on Retroviruses and Opportunistic Infections in Washington, D.C., on Sunday, January 26 at 9:30 a.m. Dr. Lederman is director of the AIDS Clinical Trials Unit (ACTU) at University Hospitals of Cleveland and Case Western University.

Recent studies indicate that people who respond to highly active antiretroviral therapy (HAART) -- drug combinations that include protease inhibitors -- can experience decreased plasma levels of HIV, increased circulating CD4+ T cell counts, decreased risk of opportunistic infections and decreased short-term mortality.

However, ACTG 315 is the first study to probe the immunologic consequences of such therapy. This became possible last spring after the recompetition for ACTG funding included an award to establish the ACTG Immunology Advanced Technology Laboratories. This network of 16 immunology laboratories has since set up standardized immunologic assays and now serves the ACTUs that comprise the ACTG. "ACTG 315 is the first field-test of this new scientific capability within the ACTG," comments NIAID's Lawrence Fox, M.D., Ph.D., medical officer in the Division of AIDS HIV Medical Research Branch.

"The significance of this study," says Dr. Lederman, " is that it will give us real clues to how the immune response recovers after therapy."

ACTG 315 enrolled 53 men and women with CD4+ T-cell counts between 100 and 3

Contact: Laurie K. Doepel
NIH/National Institute of Allergy and Infectious Diseases

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