Evaluation of a Blood Test to Measure Immune Function in HIV Positive People Compared With HIV Negative People (QFM)
The health of the immune system in HIV infected people is currently determined from a blood test measuring the number of cluster of differentiation 4 (CD4) T lymphocytes. These cells play a critical role in an immune response. Studies have shown that low numbers (below the normal range) of CD4 T lymphocytes indicates a defect in the immune system. Conversely, the number of CD4 T lymphocytes within the normal range generally indicates a normal immune system. When a person is infected with HIV the CD4 T lymphocytes are attacked and destroyed and the numbers decline meaning that the immune system can no longer effectively protect the body from infection or cancers. However, when the HIV infected person is successfully treated with Highly Active Antiretroviral Therapy (HAART) the CD4 T lymphocytes numbers increase and may end up in the normal range but the immune system may still not function properly as a number of these cells are incapable of functioning properly.
It would be interesting to know how functional the immune system is rather than the number of cells. For this, the QuantiFERON® Monitor (QFM or CST007) test is an experimental diagnostic test used in this study to measure the immune function from people infected with HIV. The objective of this study is to evaluate the usefulness of the QFM test in HIV infected people compared with uninfected people by measuring the function of the immune system. The QFM test measures interferon-gamma released in the plasma following incubation of heparinised whole blood with a combination of stimulants. As immune function is directly influenced by cells with actively replicating HIV an additional research test called the HIV Reservoir Test will be included to better understand the level of immune function in each study subject.
How long will it take? One visit for about 1 hour with Dr. Gatpolintan and his Clinical Study Coordinator to answer questions, then about 10 minutes for a blood draw (nine blocks from Dr. Gatpolintan' office).
Study outcome measures (Correlation between QFM and CD4 counts and CD4/CD8 ratios) will be assessed, including data presentation, within an average period of 1 year after study subject enrollment.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||QuantiFERON® Monitor Test to Evaluate Immune Function in HIV Infected and Uninfected Control Study Subjects|
- Correlation between QFM and CD4 counts and CD4/CD8 ratios [ Time Frame: Study outcome measures (Correlation between QFM and CD4 counts and CD4/CD8 ratios) will be assessed, including data presentation, within an average period of 1 year after study subject enrollment. ] [ Designated as safety issue: No ]How long will it take? One visit for about 1 hour with Dr. Gatpolintan and his Clinical Study Coordinator to answer questions, then about 10 minutes for a blood draw (nine blocks from Dr. Gatpolintan' office).
Biospecimen Retention: Samples With DNA
A portion of the study blood sample collected for the HIVVR test will be banked for future HIV research using the HIVVR test. Specifically, this future research will involve the HIVVR test for additional cell associated markers relating to HIV pathogenesis including (for example) other markers of activation and senescence, apoptosis (programmed cell death) and chemokine receptors (for HIV tropism).
|Study Start Date:||July 2013|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01904201
|United States, California|
|Sutter Street Internal Medicine|
|San Francisco, California, United States, 94109|
|Principal Investigator:||Tarek Elbeik, Ph.D.||Elbeik Associates, LLC|
|Study Chair:||Misato Miyamasu, Ph.D.||QIAGEN Gaithersburg, Inc|
|Study Director:||Jackie Yu, M.S.||QIAGEN Gaithersburg, Inc|
|Study Director:||Diana Cundall, B.Sc.||QIAGEN Gaithersburg, Inc|