New Trials in NovemberReturn to The Insider: News & Views
October 31 2012
Since expanding our clinical trials program earlier this year to include other infectious diseases, we have seen significant growth in our clinic. In November, we will begin recruiting for three new trials with three different pharmaceutical companies – EMD Serono, Inc., Abbott Laboratories, and Becton Dickinson.
EMD Serono, Inc – This study focuses on the drug, Egrifta, which helps reduce HIV-associated lipodystrophy. Lipodystrophy, also known as fat redistribution, is the reduction of fat in areas of the body such as the face, arms, legs and buttocks, and the accumulation of fat in areas of the body such as the gut, back of the neck, and chest. Lipodystrophy is an adverse effect of HIV infection and some studies suggest that certain antiretroviral medications can either cause or contribute to the development of the disease. Egrifta, a synthetic growth hormone-releasing factor, reduces fat accumulation in the areas of the body affected by lipodystrophy. Although Egrifta is already approved by the FDA for HIV associated lypodystrophy, the FDA requires the makers of Egrifta to study the impact of Egrifta on the progression of diabetic retinopathy. This is a three-year, multi-site study. Trial volunteers must be HIV-positive, diabetic, and experience lipodystrophy.
Abbott Laboratories – This is a blood collection study that will be used for assay validation, or testing the accuracy of new testing platforms. This trial will confirm whether certain diagnostic assays can accurately detect and confirm positive blood samples for antibodies to various antigens such as HIV, Hepatitis B, Hepatitis C, and HTLV. This is a multi-site study in which the sponosor is looking for trial volunteers who have either been exposed to, or have tested positive for, HIV, Hepatitis C, Hepatitis B, or Human T-lymphotropic Virus (HTLV).
Becton Dickinson – This blood collection study tests collection tube technology to ensure that the integrity of blood samples is being maintained. This is a multi-site study seeking trial volunteers who have tested positive for HIV, Hepatitis C, Hepatitis B, Chagas Disease (T-Cruzi), HTLV, or syphilis.