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

This study has been completed.
Information provided by (Responsible Party):
Gen-Probe, Incorporated Identifier:
First received: December 31, 2013
Last updated: February 22, 2017
Last verified: February 2017
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.

HIV-1 Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Gen-Probe, Incorporated:

Primary Outcome Measures:
  • Quantitative detection of HIV-1 RNA [ Time Frame: single baseline visit ]
    Regression parameters (intercept and slope) will be estimated from method comparison analysis.

Biospecimen Retention:   Samples With DNA

Enrollment: 468
Study Start Date: January 2014
Study Completion Date: January 2017
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Study Population


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02026752

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

Responsible Party: Gen-Probe, Incorporated Identifier: NCT02026752     History of Changes
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 )
Study First Received: December 31, 2013
Last Updated: February 22, 2017 processed this record on April 28, 2017