The National Institute of Allergy and Infectious Diseases has stopped enrollment into a large international HIV/AIDS trial comparing continuous antiretroviral therapy with episodic drug treatment based on levels of CD4 cells.
Interim data from the trial, Strategies for Management of Anti-Retroviral Therapy, or SMART, revealed that patients receiving episodic therapy had twice the risk of disease progression, the major outcome of the study, as well as increases in major complications such as cardiovascular, kidney, and liver diseases.
In the trial, volunteers with HIV were randomly assigned to a viral suppression strategy, in which antiretroviral therapy was taken on an ongoing basis, or a drug conservation strategy, in which antiretroviral therapy was started only when the levels of CD4 cells dropped below 250/μL and was stopped whenever CD4 cells were above 350/μL (http://www.smart-trial.org). As of January 11, when enrollment was stopped, 5472 volunteers had joined the study and average follow-up was approximately 15 months.
Investigators received recommendations to reinitiate antiretroviral therapy in patients in the drug conservation arm. Follow-up visits will continue for all participants in the trial as reasons for the increased risk are investigated and as plans for longer follow-up are considered.
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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