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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gen-Probe, Incorporated
ClinicalTrials.gov Identifier:
NCT02026752
First received: December 31, 2013
Last updated: November 13, 2014
Last verified: November 2014

December 31, 2013
November 13, 2014
January 2014
December 2014   (final data collection date for primary outcome measure)
Quantitative detection of HIV-1 RNA [ Time Frame: single baseline visit ] [ Designated as safety issue: No ]
Regression parameters (intercept and slope) will be estimated from method comparison analysis.
Quantitative detection of HIV-1 RNA to aid in the diagnosis of HIV-1 infection and for assessment of viral response to antiretroviral treatment [ Time Frame: approximately one year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT02026752 on ClinicalTrials.gov Archive Site
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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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

plasma

Non-Probability Sample

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

HIV-1 Infection
Not Provided
Study Population
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
468
February 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02026752
HIVQPS-US12-001, HIVQPS-US12-002, HIVQPS-US12-003, HIVQPS-US12-004
No
Gen-Probe, Incorporated
Gen-Probe, Incorporated
Not Provided
Study Director: Renee Wait Director
Gen-Probe, Incorporated
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP