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| Experimental Study Jan 24, 2010 This is probably a tough question but I would like to ask anyway. I have participated in an experimental vaccine study - Vaccination of HIV-1 infected patients with dendritic cells in addition to antiretroviral treatment - (DALIA Trial). My T-4 count was 720 with a percentage of 29% with no viral load before the vaccine. After the first vaccine my T-4 dropped to 550 with a percentage of 31% and kept dropping as I received more vaccine but still no viral load. After all 4 vaccines my T-4 was 406 with a percentage of 33% and no viral load. Suddenly it jumped to 587 with a percentage of 33% but now is at 375 with a percentage of 33% and no viral load. I know counts jump around but they seem to just keep getting lower. I have now stopped all my med in accordance with the study and I am horrified that they are now going to take a nose dive and I will also have a viral load. Could this vaccine have damaged my immune system? Is there any hope of my T-4 count ever getting back to the 700's? I am affraid that this vaccine has done more harm than good. Any advice? |
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Response from Dr. Holodniy
A couple of points about clinical trials in general and this study in particular. First, you always have the right to withdraw from the study at any time, for any reason, if you so choose. Clinical trials for the most part try to reduce the risks, but by nature, especially with experimental medications, are not no risk. Second, in this particular trial if I understand the rules, you are to be off HIV treatment for 24 weeks, after which treatment would be resumed. In addition, there are stopping rules (meaning you would immediately go back on treatment during the study) if your CD4 count drops below 350 and/or 25% on two consecutive measurements. So you have a couple of insurance policies around the study. | ||||||||||
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