Long‐Cycle Structured Intermittent versus Continuous Highly Active Antiretroviral Therapy for the Treatment of Chronic Infection with Human Immunodeficiency Virus: Effects on Drug Toxicity and on Immunologic and Virologic Parameters

Open Access

1 August 2003

journal article
clinical trial
Published by Oxford University Press (OUP) in The Journal of Infectious Diseases

Vol. 188 (3) , 388-396
https://doi.org/10.1086/376535

Abstract

We evaluated the effect of long-cycle structured intermittent therapy (SIT; 4 weeks without highly active antiretroviral therapy [HAART] followed by 8 weeks with HAART) versus continuous HAART. The study was prematurely terminated to new enrollment because of the emergence of genetic mutations associated with resistance to antiretroviral drugs in 5 patients. After 48 weeks, there was no significant difference between groups in lipid, hepatic transaminase, and C-reactive protein levels in 41 patients. Although there were no differences in CD4⁺ or CD8⁺ T cell counts or the percentage of cells that were CD4⁺CD25⁺, CD8⁺CD25⁺, or CD4⁺DR⁺, patients who received SIT had a significantly higher percentage of CD8⁺CD38⁺ and CD8⁺DR⁺ cells. There was no clear autoimmunization effect by immunologic or virologic parameters. There was no benefit to long-cycle SIT versus continuous HAART with regard to certain toxicity, immunologic, or virologic parameters.

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