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

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• Subject already participated in this study and subject's previous sample(s) was provided and not withdrawn (ie, subject has an evaluable sample in the study)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