Evaluation of a Blood Test to Measure Immune Function in HIV Positive People Compared With HIV Negative People
Public ClinicalTrials.gov record NCT01904201. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
QuantiFERON® Monitor Test to Evaluate Immune Function in HIV Infected and Uninfected Control Study Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01904201
- Recruitment status
- Terminated
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 57 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2013
- Primary completion
- May 31, 2014
- Completion
- May 31, 2014
- Last update posted
- Jul 8, 2014
2013 – 2014
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sutter Street Internal Medicine | San Francisco | California | 94109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01904201, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 8, 2014 · Synced Sep 15, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01904201 live on ClinicalTrials.gov.