NCT01032902

Brief Summary

This study has been designed to evaluate the performance of the Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 rapid test. The device is intended to qualitatively detect the presence of antibodies against HIV-1/2 in oral fluid, whole blood (capillary and venous), serum or plasma. This study will assess the DPP® HIV 1/2 Screen assay's ability to detect HIV-1.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,808

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2009

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 30, 2012

Status Verified

April 1, 2012

Enrollment Period

2.2 years

First QC Date

December 15, 2009

Last Update Submit

April 27, 2012

Conditions

HIV Infections

Keywords

Human immunodeficiency virusRapid TestHIVHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • The device detects HIV-1 antibodies in a variety of sample matrices: capillary whole blood, venous whole blood (with EDTA or heparin anticoagulant), oral fluid, serum and plasma (with EDTA or heparin anticoagulant).

    20 minutes

Secondary Outcomes (1)

  • The device provides a qualitative screen for the detection of antibodies to HIV-1 compared to an FDA approved HIV-1/2 EIA, with sensitivity and specificity equal to or greater than 98% at the lower 95% confidence interval boundary.

    20 minutes

Study Arms (3)

Known HIV positive

Patients from HIV clinics with documented infections

Device: In Vitro Diagnostic Device

High Risk for Infection with HIV

Patients from defined HIV high-risk populations - i.e. intravenous drug users, or patients presenting with symptoms of sexually transmitted disease.

Device: In Vitro Diagnostic Device

Low-Risk for Infection with HIV

Individuals not known to belong to any of the defined high-risk groups - i.e. "healthy patients" presenting for routine physicals or other unrelated non-life threatening illnesses, or individuals from a general low risk population such as students, employees of academic or other institutions, etc…

Device: In Vitro Diagnostic Device

Interventions

In Vitro Diagnostic DeviceDEVICE

For the detection of antibodies to HIV in serum, plasma, blood and oral fluid

High Risk for Infection with HIVKnown HIV positiveLow-Risk for Infection with HIV

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Point-of-care test sites including clinics and physician office settings

You may qualify if:

  • Must be at least 2 years of age (no upper age limit).
  • Must be willing and able to receive post-test counseling, if applicable.
  • Must sign (and be given) a copy of the written Informed Consent form and or Assent form (if applicable).
  • Must be able to sustain fingersticks and venipuncture from the arm or hand only.

You may not qualify if:

  • Am in a life threatening condition at the time of enrollment
  • Have a suppressed immune systems (i.e. transplant patients, individuals diagnosed with non-HIV immunosuppressive illness, etc.).
  • Have participated or are participating in a clinical trial for an HIV vaccine.
  • Have previously participated in this clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Univeristy of California, San Diego

La Jolla, California, 92093, United States

Location

Therafirst

Fort Lauderdale, Florida, 33308, United States

Location

University of Maryland

Baltimore, Maryland, 21201-1559, United States

Location

St. Christopher's Hospital for Children/ Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

University of Texas HSC

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Reagent Kits, Diagnostic

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Uses of ChemicalsPharmacologic ActionsChemical Actions and UsesIndicators and ReagentsLaboratory ChemicalsSpecialty Uses of ChemicalsEquipment and Supplies

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2009

First Posted

December 16, 2009

Study Start

January 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 30, 2012

Record last verified: 2012-04

Locations

US(5)