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Issue No. 11 | March 11, 2011

News and Features

NIH Study Will Examine Best Time for Healthy HIV-Infected People to Begin Antiretroviral Medications

“A major new clinical trial seeks to determine whether HIV-infected asymptomatic individuals have less risk of developing AIDS or other serious illness if they begin taking antiretrovirals sooner rather than later, based on their level of CD4+ T-cells. … The study is co-funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

“… guidelines differ with regard to if and when to begin antiretroviral treatment in asymptomatic HIV-infected individuals with CD4 counts above 350 cells/mm³. …

“The new Phase IV study, known as the Strategic Timing of Antiretroviral Treatment (START) clinical trial, is a randomized clinical trial designed to provide definitive evidence of the risks and benefits of early antiretroviral treatment to more clearly define the optimal time to begin medication. It seeks to determine if immediate antiretroviral therapy among HIV-infected individuals with CD4 levels above 500 cells/mm³ is better than deferring treatment until CD4 counts fall below 350 in terms of potential benefits and risks, such as developing AIDS and other serious illnesses, including cardiovascular disease, cancer, kidney failure, and liver disease, or death. …

“START will be conducted in 30 countries. It will enroll 4,000 HIV-infected men and women 18 years of age and older who have CD4 counts above 500 cells/mm³ and who have never taken antiretroviral therapy. Once entered into the study, half of the participants will be assigned randomly to receive immediate antiretroviral therapy. The other half of the study group will not receive antiretroviral therapy until their CD4 counts fall below 350 cells/mm³ or an AIDS-related event occurs.”

More information is available:

CDC Updates HIV Mortality Slide Set

The Centers for Disease Control and Prevention (CDC) recently updated the “HIV Mortality (through 2007)” slide set. The slide set provides information on HIV-related mortalities in the United States, including breakdowns of mortalities by age group, geographic region, and race/ethnicity.

Study Suggests Integrase Resistance-Associated Mutations Can Occur During Episodes of Low-Level Viremia

“The emergence of integrase strand-transfer inhibitor (INSTI) resistance-associated mutations was examined in patients with low-level viremia after switching from enfuvirtide to raltegravir in the ANRS 138-Easier trial. …

“Integrase genes of plasma virus from raltegravir-treated patients in the Easier trial with low-level viremia (50-500 copies/ml) were sequenced to determine INSTI resistance-associated mutations. …

“Forty-nine patients experienced at least one episode of low-level viremia while receiving raltegravir; integrase genotyping was successful in samples from 39 individuals (80%). Among them, three [7.7%, 95% confidence interval (CI) 1.6-20.9%] had significant INSTI resistance mutations consisting of N155H in two and P145S in one. Absence of these mutations from proviral DNA at baseline suggested selection of INSTI resistance during episodes of low-level viremia. No specific factors significantly associated with emergence of INSTI resistance mutations during low-level viremia were identified. …

“Emergence of INSTI resistance mutations can occur during episodes of low-level viremia in patients receiving raltegravir-containing regimens.”

More information is available: