Trial record 2 of 39 for:    " June 26, 2013":" July 26, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
QIAGEN Gaithersburg, Inc
ClinicalTrials.gov Identifier:
NCT01904201
First received: July 11, 2013
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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.


Condition
HIV Positive

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by QIAGEN Gaithersburg, Inc:

Primary Outcome Measures:
  • 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).


Enrollment: 57
Study Start Date: July 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Key Exclusion Criteria for all HIV Infected only:

  • Primary infection: < 6 months after documented HIV-1 antibody positive test

Key Exclusion Criteria for drug naïve HIV Infected only

  • Ended HIV medications less than 2 months before the study

Key Exclusion Criteria for HIV uninfected only:

  • On HIV-1 pre-or post exposure prophylaxis <21 days before enrolment

Key Exclusion Criteria for all subjects:

  • <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.
  • Previous therapy with agents with systemic myelosuppressive, pancreotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment
  • On therapy that suppresses bone marrow, toxic to liver and pancreas
  • On ongoing therapy that is toxic to kidneys including aminoglycoside antibiotics, amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, other agents with significant nephrotoxic potential
  • Creatinine clearance < 60 mL/min
  • On anti-cancer therapy
  • On ongoing therapy with immunosuppressive agents
  • On ongoing chemotherapeutic agents
  • On ongoing systemic corticosteroids
  • On ongoing systemic interleukin 2 or other cytokine therapy
  • Anticonvulsants (eg. Carbamazepine, Phenytoin, Valproate)
  • Monoclonal antibody therapy (eg. Muromonab OKT3)
  • Any other prior therapy that, in the opinion of the PI, would make the subject unsuitable for the study.

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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01904201

Locations
United States, California
Sutter Street Internal Medicine
San Francisco, California, United States, 94109
Sponsors and Collaborators
QIAGEN Gaithersburg, Inc
Investigators
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
  More Information

No publications provided

Responsible Party: QIAGEN Gaithersburg, Inc
ClinicalTrials.gov Identifier: NCT01904201     History of Changes
Other Study ID Numbers: CST007_03
Study First Received: July 11, 2013
Last Updated: July 7, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by QIAGEN Gaithersburg, Inc:
Immune function
Interferon-gamma release assays
Active HIV cell Reservoirs

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014