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provided and not withdrawn (ie, subject has an evaluable sample in the study)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