Collection of Samples From HIV-1 Infected Individuals for Evaluation of the Aptima HIV-1 Assay

Collection of Plasma Samples From Human Immunodeficiency Virus (HIV) Type 1 (HIV-1) Infected Individuals for the Clinical Evaluation of the Aptima HIV-1 Quant Dx Assay

The objective is to obtain plasma samples from Human Immunodeficiency Virus Type 1 (HIV-1) infected individuals that have viral loads across the dynamic range of the Aptima HIV-1 assay. The plasma samples will be tested in a method comparison study to support the approval of the Aptima HIV-1 assay on Gen-Probe's Panther testing system. The objective of the method comparison study is to evaluate the clinical utility of the Aptima HIV-1 assay by comparing the results to the FDA-licensed COBAS assay (Roche Molecular Systems, Inc., Branchburg, New Jersey) in plasma samples that have viral loads across the dynamic range of the Aptima HIV-1 assay.

Study Overview

• Status: Completed
• Conditions: HIV-1 Infection

• Study Type: Observational
• Enrollment (Actual): 468

Contacts and Locations

Study Locations

• United States
  • California
    • Palm Springs, California, United States, 92262
      • Palmtree Clinical Research Inc
    • San Diego, California, United States, 92103
      • UCSD - AnitViral Research Center (AVRC)
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami - AIDS Clinical Research Unit
    • Sarasota, Florida, United States, 34237
      • Community AIDS Network
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Wishard Health Services
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • New York
    • Bronx, New York, United States, 10461
      • Jacobi Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV-infected male and female subjects ≥15 years of age who are attending participating US medical facilities will be eligible to enroll. Participating sites may include academic institutions with clinical divisions, infectious disease clinics, and other medical facilities such as sexually transmitted infection, HIV, and public health facilities

Description

Inclusion Criteria

• The subject has documented HIV infection
• The subject is at least 15 years of age at the time of enrollment
• For ART subjects, subject has documented HIV-1 RNA levels above the lower limit of quantitation of an FDA-approved assay in a sample collected in the past 90 days.
• The subject (and/or legally authorized representative, if allowed) is willing and able to provide written informed consent before providing a specimen (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an institutional review board [IRB]-approved waiver for parental consent for minors).

Exclusion Criteria

• A potential subject will be ineligible for the study if the subject, clinician, or medical record reports any of the following:
• Subject's HIV disease stage and/or current ART status is unknown.
• It is unknown if current or previous ART was changed or stopped due to therapy failure.
• For non-ART subjects, subject was previously on ART in the past 30 days
• Subject already participated in this study and subject's previous sample(s) was provided and not withdrawn (ie, subject has an evaluable sample in the study)
• Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the study
• Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled in the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Study Population

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative detection of HIV-1 RNA	Regression parameters (intercept and slope) will be estimated from method comparison analysis.	single baseline visit

Collaborators and Investigators

• Sponsor: Gen-Probe, Incorporated
• Investigators: Study Director: Renee Wait, Director

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: December 31, 2013
• First Submitted That Met QC Criteria: December 31, 2013
• First Posted (Estimate): January 3, 2014

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HIVQPS-US12-001; HIVQPS-US12-002 (Other Identifier: Gen-Probe); HIVQPS-US12-003 (Other Identifier: Gen-Probe); HIVQPS-US12-004 (Other Identifier: Gen-Probe)