Clinical Performance of Reveal G4 Rapid HIV-1 Antibody Test

NCT02190578 | Completed

• 1 other identifier: MCP005
• Study Type: interventional
• Target: 1,649
• Locations: 1 country
• Sites: 4

Brief Summary

To determine the efficacy of an improved rapid diagnostic test using venous whole blood and fingerstick whole blood. The clinical performance of Reveal G4 Rapid HIV-1 Antibody Test will be determined by comparing the results with patient infected status for HIV-1 (human immunodeficiency virus type 1). The study will consist of a single one-hour visit, at which time blood samples will be collected and tested with the investigational device (Reveal G4) and FDA approved comparator assays for detection of HIV-1 antibodies.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Determine clinical performance of Reveal G4

  To determine the clinical performance of Reveal G4 with fingerstick and venous whole blood relative to the HIV-1 infected status of the patient

  At single study visit (one hour)

Study Arms (1)

Diagnostic: Reveal G4

EXPERIMENTAL

Subjects tested with investigational devices and approved comparator assay algorithms for HIV

Device: Reveal G4

Interventions

Reveal G4 DEVICE

All subjects tested with the investigational device, Reveal G4, plus with an algorithm of approved assays for HIV.

Also known as: Reveal Rapid HIV-1 Antibody Test

Diagnostic: Reveal G4

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 must be at least 18 years of age, able to sign consent form, complete the risk assessment questionnaire, and provide the required blood samples: fingerstick sample (1 drop), venous whole blood sample (1 K2 EDTA tube).
• Population 1 - Individuals at risk of HIV infection (n ≥ 500) Subjects must meet have at least one risk factor for infection with HIV
• Population 2 - Known HIV-1 positive individuals (n ≥ 500) Subjects must be a known HIV-positive individual (previous positive HIV test result)
• Population 3 - Individuals at low risk of HIV infection (n ≥ 500) Subjects must not have any risk factors for infection with HIV

Sponsors & Collaborators

• MedMira Laboratories Inc.: lead

Study Sites (4)

Preventive Medicine, University of Southern California (Los Angeles)

Los Angeles, California, 90007, United States

Location

Therafirst Medical Center

Fort Lauderdale, Florida, 33308, United States

Location

New York City Department of Health and Mental Hygiene

Queens, New York, 11101, United States

Location

Biological Specialty Corporation

Reading, Pennsylvania, 19602, 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

• Fabienne Laraque, MD

  New York City Department of Health and Mental Hygiene

  PRINCIPAL INVESTIGATOR

• Peter Kerndt, MD

  University of Southern California - Los Angeles

  PRINCIPAL INVESTIGATOR

• Cheryl Berne, MD

  Biological Specialties Corporation

  PRINCIPAL INVESTIGATOR

• Anthony LaMarca, MD

  Therafirst Medical Center

  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 11, 2014
• First Posted: July 15, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 24, 2015

Record last verified: 2014-07

Locations

US (4)