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

Gen-Probe

Status: Completed

Conditions: HIV-1 Infection

Study type: Observational

Funder types: Industry

Identifiers

NCT02026752

HIVQPS-US12-002 (Other Identifier)

HIVQPS-US12-001

HIVQPS-US12-003 (Other Identifier)

HIVQPS-US12-004 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 468 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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• Subject already participated in this study and subject's previous sample(s) was provided and not withdrawn (ie, subject has an evaluable sample in the study)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

Trial design

468 participants in 1 patient group

Study Population