Rapid Diagnostics for HIV and Hepatitis

NCT02190305 | Withdrawn

• 1 other identifier: MCP002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

HIV Infections; Hepatitis B Infections; Hepatitis C Infections

Outcome Measures

Primary Outcomes (1)

• Clinical performance of Reveal HBsAg and Multiplo HBc/HIV/HCV

  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.

  At single study visit

Study Arms (1)

Diagnostic: Multiplo HBc/HIV/HCV + Reveal HBsAg

EXPERIMENTAL

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

Interventions

Multiplo HBc/HIV/HCV and Reveal HBsAg DEVICE

All subjects tested with both investigational devices, plus with algorithms of approved assays for HIV and hepatitis B and C.

Also known as: Multiplo Rapid HBc/HIV/HCV Antibody Test, Reveal Rapid Hepatitis B Surface Antigen Test

Diagnostic: Multiplo HBc/HIV/HCV + Reveal HBsAg

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects:
• 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)
• 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:

Sponsors & Collaborators

• MedMira Laboratories Inc.: lead

Study Sites (4)

Keck School of Medicine - LAUSC

Los Angeles, California, 90089-9239, United States

Location

SCFLD Hepatology Diagnostic Research Laboratory

Miami, Florida, 33136, United States

Location

Minneapolis Medical Research Foundation

Minneapolis, Minnesota, 55404, United States

Location

NYC Dept Health & Mental Hygiene

New York, New York, 11101, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 15, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

US (4)