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Evaluation of a Blood Test to Measure Immune Function in HIV Positive People Compared With HIV Negative People

NCT01904201 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 57

Last updated 2014-07-09

No results posted yet for this study

Summary

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.

Conditions

  • HIV Positive

Sponsors & Collaborators

  • QIAGEN Gaithersburg, Inc

    lead INDUSTRY

Principal Investigators

  • Tarek Elbeik, Ph.D. · Elbeik Associates, LLC

  • Misato Miyamasu, Ph.D. · QIAGEN Gaithersburg, Inc

  • Jackie Yu, M.S. · QIAGEN Gaithersburg, Inc

  • Diana Cundall, B.Sc. · QIAGEN Gaithersburg, Inc

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01904201 on ClinicalTrials.gov