Rapid Diagnostics for HIV and Hepatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by MedMira Laboratories Inc.
Sponsor:
Information provided by (Responsible Party):
MedMira Laboratories Inc.
ClinicalTrials.gov Identifier:
NCT02190305
First received: July 9, 2014
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to determine the efficacy of two rapid diagnostic tests in plasma, venipuncture whole blood, and fingerstick whole blood. The clinical performance of Multiplo HBc/HIV/HCV will be determined by comparing the results with patient infected status for HIV-1/2 (human immunodeficiency viruses 1 and 2), HBV (hepatitis B virus) and HCV (hepatitis C virus). The clinical performance of Reveal HBsAg will be determined by comparing the results with patient infected status for HBV.

Subject participation in the study will consist of a single one-hour visit, at which time blood samples will be drawn for testing with the investigational devices and with approved comparator assays. The test results, which are the outcome of the study, will be obtained only once, at the time of this visit.


Condition Intervention
HIV Infections
Hepatitis B Infections
Hepatitis C Infections
Device: Multiplo HBc/HIV/HCV and Reveal HBsAg

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Rapid Diagnostics for HIV and Hepatitis - Multiplo HBc/HIV/HCV and Reveal HBsAg

Resource links provided by NLM:


Further study details as provided by MedMira Laboratories Inc.:

Primary Outcome Measures:
  • Clinical performance of Reveal HBsAg and Multiplo HBc/HIV/HCV [ Time Frame: At single study visit ] [ Designated as safety issue: No ]

    For each enrolled subject, Multiplo HBc/HIV/HCV and Reveal HBsAg devices will be used to test finger stick whole blood, venipuncture whole blood, and plasma samples. Plasma will also be tested using separate algorithms of FDA approved assays to determine patient infected status for HIV-1/2, hepatitis B, and hepatitis C.

    The performance of Reveal HBsAg will be determined relative to patient infected status for hepatitis B for each matrix assessed. The performance of Multiplo HBc/HIV/HCV will be determined relative to patient infected status for each of hepatitis B, HIV-1/2, and hepatitis C.



Estimated Enrollment: 4000
Study Start Date: May 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic: Multiplo HBc/HIV/HCV + Reveal HBsAg
Subjects tested with investigational devices and approved comparator assay algorithms for HIV and hepatitis B and C.
Device: Multiplo HBc/HIV/HCV and Reveal HBsAg
All subjects tested with both investigational devices, plus with algorithms of approved assays for HIV and hepatitis B and C.
Other Names:
  • Multiplo Rapid HBc/HIV/HCV Antibody Test
  • Reveal Rapid Hepatitis B Surface Antigen Test

Detailed Description:

The objective of this study is to determine the performance characteristics of two rapid diagnostic tests.

Approximately 3000-4500 subjects in total will be enrolled in the study into four different study populations. In Population 1, which is "at risk" group of about 2000-3000 subjects, roughly 2/3 will be individuals who are at risk of infection with HIV or hepatitis B or C, or who have signs or symptoms of hepatitis. Approximately 500 of these individuals are expected to be known HIV-positive individuals.

The remaining three study populations will be comprised of individuals with known infection with HIV (Population 1A, ~500 individuals), HBV (Population 1B, ~500 individuals), and HCV (Population 1C, ~500 individuals).

Both Multiplo HBc/HIV/HCV and Reveal HBsAg will be used to test finger stick whole blood, venous whole blood and plasma samples from each subject in Population 1. Plasma samples (repository or fresh) will be used to fulfill the requirements for Populations 1A, 1B, and 1C.

For all enrolled subjects, the plasma sample will be tested with the following FDA-approved assays: EIA for anti-HIV-1/2, anti-HCV, anti-HBc total, anti-HBc IgM, anti-HBs, and HBsAg. The efficacy of Multiplo will be determined by comparing the results with patient infected status for HIV-1/2, HBV and HCV. The efficacy of Reveal will be determined by comparing the results with patient infected status for HBV.

The primary analysis will involve comparison of Multiplo HBc/HIV/HCV and Reveal HBsAg results for each of the test markers (anti-HIV-1/2, anti-HCV, anti-HBc, and HBsAg), in each sample matrix (finger stick whole blood, venous whole blood and plasma) with the patient infected status as determined by separate algorithms for HIV, HBV, and HCV. The percent positive and percent negative agreement will be determined relative to patient infected status for each marker and sample type, with corresponding two-sided 95% confidence intervals.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All subjects:

  • 13 years of age or older
  • able to sign consent form (or parent/guardian sign consent plus subject sign assent for ages 13-18)
  • willing to complete the risk assessment questionnaire, and
  • willing to provide blood samples: finger stick sample (2 drops), 1 serum separator tube, 2 anticoagulant (K2 EDTA) tubes.

Population 1 - Diagnostic Trial "At Risk" Group (n = 2000-3000)

Subjects must meet one or more of the following inclusion criteria to be enrolled in Population 1:

  • Have at least one risk factor for infection with hepatitis B or C,
  • Have at least one risk factor for infection with HIV,
  • Present with signs and symptoms of hepatitis,
  • Be a known HIV-positive individual (previous positive HIV test result, may comprise up to 500 individuals)

Population 1A - Additional known HIV-positive individuals (n = ~500)

Subjects must:

• be a known HIV-positive individual (previous positive HIV test result).

Population 1B - Additional known HBV-positive individuals (n = ~500)

Subjects must:

• be known to have current or past HBV infection, as evidenced by HBV serology results.

Population 1C - Additional known HCV-positive individuals (n = ~500)

Subjects must:

• be known to be infected with HCV, as evidenced by previous positive HCV test results.

Exclusion Criteria:

  • Subjects do not meet the inclusion criteria
  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: NCT02190305

Locations
United States, California
Keck School of Medicine - LAUSC Not yet recruiting
Los Angeles, California, United States, 90089-9239
Contact: Peter Kerndt, MD    310-905-2871    pkerndt@usc.edu   
United States, Florida
SCFLD Hepatology Diagnostic Research Laboratory Recruiting
Miami, Florida, United States, 33136
Contact: Maria D DeMedina    305-243-6500      
Principal Investigator: Eugene R Schiff         
United States, New York
NYC Dept Health & Mental Hygiene Not yet recruiting
New York, New York, United States, 11101
Contact: Fabienne Laraque, MD    347-396-7415    flaraque@health.nyc.gov   
Sponsors and Collaborators
MedMira Laboratories Inc.
Investigators
Principal Investigator: Eugene Schiff, MD University of Miami
Principal Investigator: Peter Kerndt, MD University of Southern California - Los Angeles
Principal Investigator: Fabienne Laraque, MD New York City Department of Health and Mental Hygiene
  More Information

No publications provided

Responsible Party: MedMira Laboratories Inc.
ClinicalTrials.gov Identifier: NCT02190305     History of Changes
Other Study ID Numbers: MCP002
Study First Received: July 9, 2014
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis C
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on September 18, 2014