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Issue No. 50 | December 11, 2009

News and Features

NIAID 2009 H1N1 Vaccine Study Now Enrolling HIV-Infected Adults

"HIV-infected adults currently are being recruited to participate in a clinical trial of 2009 H1N1 influenza vaccine. The study, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health, will enroll approximately 240 men and women between the ages of 18 and 64. 
"'People with suppressed immunity caused by conditions such as HIV infection are at increased risk of serious illness from 2009 H1N1 influenza, and should be vaccinated against the H1N1 virus,' says NIAID Director Anthony S. Fauci, M.D.

"'However, such immune suppression may hamper the response to influenza vaccines,' Dr. Fauci adds. 'While people with HIV infection are a high-priority group to receive 2009 H1N1 influenza vaccine, the optimal dosage of 2009 H1N1 vaccine for people with HIV infection has not been determined through clinical trials. This study will help address that gap in knowledge.'

"All study participants will receive two doses of an inactivated 2009 H1N1 influenza vaccine, administered approximately 21 days apart. The vaccine is manufactured by Novartis. Half of the volunteers will receive two 15-microgram doses and the other half two 30-microgram doses of the vaccine."

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Fosamprenavir (Lexiva) Prescribing Information Updated

"GlaxoSmithKline (GSK) and FDA are notifying healthcare professionals and others of a potential association between Lexiva and myocardial infarction (heart attack) and dyslipidemia (abnormal concentrations of lipids or lipoproteins in the blood) in HIV infected adults. GSK has modified the existing Warnings and Precautions section of the Prescribing Information to note that increases in cholesterol have occurred with treatment, the importance of lipids management, and a recommendation that triglyceride and cholesterol testing be performed prior to initiating therapy with LEXIVA and at periodic intervals during therapy."

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Study Suggests an Increased Prevalence and Severity of Coronary Atherosclerosis in HIV-Infected Men Compared with HIV-Uninfected Men

"The degree of subclinical coronary atherosclerosis in HIV-infected patients is unknown. We investigated the degree of subclinical atherosclerosis and the relationship of traditional and nontraditional risk factors to early atherosclerotic disease using coronary computed tomography angiography.…Seventy-eight HIV-infected men (age 46.5 +/- 6.5 years and duration of HIV 13.5 +/- 6.1 years, CD4 T lymphocytes 523 +/- 282; 81% undetectable viral load), and 32 HIV-negative men (age 45.4 +/- 7.2 years) with similar demographic and coronary artery disease (CAD) risk factors, without history or symptoms of CAD, were prospectively recruited. 64-slice multidetector row computed tomography coronary angiography was performed to determine prevalence of coronary atherosclerosis, coronary stenosis, and quantitative plaque burden.…Young, asymptomatic, HIV-infected men with long-standing HIV disease demonstrate an increased prevalence and degree of coronary atherosclerosis compared with non-HIV-infected patients. Both traditional and nontraditional risk factors contribute to atherosclerotic disease in HIV-infected patients."

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