MedTrace Logo

Evaluation of Diagnostic HIV Ag/Ab Combo Assay

NCT00933933 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 635

Last updated 2011-07-12

Study results available
· View outcomes & findings →

Summary

To test blood specimens using a new investigational test that detects antigen and antibody to human immunodeficiency virus (HIV). Results will be compared to an approved HIV antibody test and supplemental testing performed to determine HIV status.

Conditions

  • Human Immunodeficiency Viruses

Interventions

DEVICE

ARCHITECT HIV Ag/Ab Combo

Test blood samples with investigational HIV assay. If results for specimens from the normal healthy population or pregnant female population at risk for HIV infection are reactive, samples will be tested with supplemental HIV assays. If all supplemental HIV assays are negative, subject will be asked to return for a follow-up blood draw.

DEVICE

ARCHITECT HIV Ag/Ab Combo

Test blood samples with investigational HIV assay. If results for specimens from the at risk population are reactive, samples will be tested with supplemental HIV assays. If all supplemental HIV assays are negative, subject will be asked to return for a follow-up blood draw when possible.

Sponsors & Collaborators

  • Abbott Diagnostics Division

    lead INDUSTRY

Principal Investigators

  • William Roberts, MD · ARUP Laboratories

  • Laurence Demers, PhD · M.S. Hershey Medical Center

  • Fred Apple, PhD · Hennepin Healthcare Research Institute

  • Michael Loeffelholz, PhD · University of Texas Medical Branch at Galveston

  • John Heffner · Clement J. Zablocki VA Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2009-10-31
Completion
2009-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00933933 on ClinicalTrials.gov