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

NCT01904201 | Terminated DMC

• 1 other identifier: CST007_03
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Immune function; Interferon-gamma release assays; Active HIV cell Reservoirs

Outcome Measures

Primary Outcomes (1)

• Correlation between QFM and CD4 counts and CD4/CD8 ratios

  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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV positive Anti-retroviral drug naïve (never on treatment, or for the last 60 days or greater off or treatment), n=30. HIV positive successful HAART for the last 24 months (or greater) with two undetectable plasma viral load within the last 12 months, n=30 HIV positive on HAART for the last 24 months (or greater) with latest plasma viral load \>200, n=30 HIV negative

You may qualify if:

• Anti-retroviral drug naïve, (never on treatment, or \>60 days off treatment), n=30
• All plasma viral load results within the last 24 months; most recent plasma viral load result of any value used for enrollment.
• All CD4 results within the last 24 months; most recent CD4 result used for enrollment: CD4\>500/microliter (uL) (n=15) or CD4\<500/uL (n=15).
• Successful HAART \> 24 months with two undetectable plasma viral load within the last 12 months, n=30
• All plasma viral load results within the last 24 months; two most recent plasma viral load results within last 12 months must be undetectable and used for enrollment.
• All CD4 results within the last 24 months; most recent CD4 result used for enrollment: CD4\>500/uL (n=15) or CD4\<500/uL (n=15).
• On HAART \> 24 months with latest plasma viral load \>200, n=30
• All plasma viral load results within the last 24 months; most recent plasma viral load result \>200 and used for enrollment.
• All CD4 results within the last 24 months; most recent CD4 result used for enrollment: CD4\>500/uL (n=15) or CD4\<500/uL (n=15).
• HIV Uninfected Controls (n=30):
• Documentation of HIV seronegative status at time of enrollment

You may not qualify if:

• Primary infection: \< 6 months after documented HIV-1 antibody positive test
• Ended HIV medications less than 2 months before the study
• On HIV-1 pre-or post exposure prophylaxis \<21 days before enrolment
• \<18 or \>65 years of age
• Pregnant or lactating subjects
• Documented hepatitis B virus (HBV) and/or hepatitis C virus (HCV) Infection
• Proven or suspected acute hepatitis
• Transient clinical manifestation (i.e., cold, flu, measles, etc). Eligible when resolved
• Evidence of a gastrointestinal malabsorption syndrome, chronic inflammatory disease (i.e. Crohn's Disease) or chronic nausea or vomiting
• Prior history of significant renal or bone disease
• Malignancy other than cutaneous Kaposi's sarcoma or basal cell carcinoma
• \< 30 days after any vaccination. Eligible 30 days post vaccination.
• Current alcohol or substance abuse
• Active, serious infections (other than HIV infection) requiring parenteral antimicrobial therapy within 30 days prior to enrollment.
• Any other clinical condition in the opinion of the PI, would make the subject unsuitable for the study i.e. active cytomegalovirus (CMV) and Epstein-Barr virus (EBV) infection, diabetes, Rheumatoid Arthritis, etc.

Sponsors & Collaborators

• QIAGEN Gaithersburg, Inc: lead

Study Sites (1)

Sutter Street Internal Medicine

San Francisco, California, 94109, United States

Location

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).

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Tarek Elbeik, Ph.D.

  Elbeik Associates, LLC

  PRINCIPAL INVESTIGATOR

• Misato Miyamasu, Ph.D.

  QIAGEN Gaithersburg, Inc

  STUDY CHAIR

• Jackie Yu, M.S.

  QIAGEN Gaithersburg, Inc

  STUDY DIRECTOR

• Diana Cundall, B.Sc.

  QIAGEN Gaithersburg, Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 22, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 9, 2014

Record last verified: 2014-07

Locations

US (1)