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Role of Labs in HIV/AIDS Clinical Trials

roleOfLabs.jpgLaboratories play a critical role in HIV/AIDS clinical trials because they test all the study participants' blood or other samples for a variety of factors. Through this testing, researchers are able to determine:

  • The integrity and usefulness of the samples
  • How many HIV virions or "particles" are in the person's blood (viral load)
  • How much damage has been done to the person's immune system (CD4 count)
  • Blood levels of therapeutic drugs, such as antiretroviral drugs (for example, integrase inhibitors and protease inhibitors)
  • The safety of a treatment through the measurement of a large number of indicators such as red blood cells, calcium, and blood sugar (glucose)
  • The presence or absence of co-infections, such as tuberculosis (TB) or malaria

In short, the laboratories generate the scientific data that is analyzed in clinical trials. The data is submitted to a statistical and data management center (SDMC) such as Frontier Science & Technology Research Foundation (FSTRF) or the Statistical Center for HIV/AIDS Research and Prevention (SCHARP) for storage and analysis.

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