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NCT01904201 · ClinicalTrials.gov registry record
Evaluation of a Blood Test to Measure Immune Function in HIV Positive People Compared With HIV Negative People
A clinical trial, sponsored by QIAGEN Gaithersburg.
- Terminated
- Registry status
- 57
- Enrollment target
NCT01904201: Clinical Trial study, sponsored by QIAGEN Gaithersburg.
NCT01904201 is a clinical trial that was terminated before completion, run by QIAGEN Gaithersburg. The registered enrollment target is 57 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01904201 was terminated before completion, sponsored by QIAGEN Gaithersburg.
- TERMINATED
- Registry status
- 57 participants
- Enrollment target
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. Gatpolinta
Primary Outcome
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).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-06 |
Why NCT01904201 stopped before completion
NCT01904201 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 57 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01904201 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01904201 about?
NCT01904201 is a clinical study titled "Evaluation of a Blood Test to Measure Immune Function in HIV Positive People Compared With HIV Negative People". 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 lym...
What is the current status of trial NCT01904201?
This trial is currently terminated. The enrollment target is 57 participants. The study started on 2013-07. Estimated completion is 2014-06.
Who is sponsoring clinical trial NCT01904201?
This trial is sponsored by QIAGEN Gaithersburg, which has 11 total clinical trials registered on ClinicalTrials.gov.
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