NIAID Halts Trial on Antiretroviral Drug Conservation Strategy After Findings Show Method Increases HIV-Positive Patients' Risk of AIDS, Death
January 19, 2006
The National Institute of Allergy and Infectious Diseases on Wednesday announced it ended enrollment in a clinical trial comparing daily antiretroviral therapy with a drug-conservation strategy, which involves taking medication intermittently, after findings showed the conservation strategy increased HIV-positive patients' risk of developing AIDS or dying, Reuters reports (Reuters, 1/19). The Strategies for Management of Antiretroviral Therapy trial -- which involved 318 sites in 33 countries -- began enrolling patients in January 2002 and included 5,472 HIV-positive participants when the trial was suspended on Jan. 11 (NIAID release, 1/18). SMART trial volunteers were randomly assigned to a daily antiretroviral therapy regimen or an episodic treatment strategy, which called for taking medication only when CD4+ T cell counts dropped below a specific level, the AP/Miami Herald reports. Previously, smaller studies indicated that taking monitored breaks from daily antiretroviral treatment might control the progression HIV while reducing some of the drugs' side effects, as well as lowering costs of the treatment regimens (Neergaard, AP/Miami Herald, 1/19). However, interim studies of the NIAID trial conducted earlier this month by the independent Data and Safety Monitoring Board showed that participants who took their medication on an irregular basis were more than twice as likely to experience increased progression of the virus or death compared with those on a daily treatment regimen (NIAID release, 1/18). Patients taking episodic treatment also were more likely to experience cardiovascular and kidney complications as well as liver disease, all of which also have been related to antiretroviral drug use (Smith, Boston Globe, 1/19).
Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork.org/dailyreports/hiv. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service of the Kaiser Family Foundation, by The Advisory Board Company. © 2006 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Gilead, Bristol-Myers Squibb Develop Once-a-Day Pill for Treating HIV; Study Shows Pill More Effective Than Standard Regimen
Argentina, Brazil to Produce Antiretroviral Drugs Together to Improve Access for HIV-Positive People
This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.