HIV-1 Infection
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Gen-Probe, Incorporated
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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in the past 30 days * Subject already participated in this study and subject's previous sample(s) was provided and not withdrawn (ie, subject has an evaluable sample in the study) * Subject has a history of illness that the principal investigator (PI) or designee considers could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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative detection of HIV-1 RNA | single baseline visit | Regression parameters (intercept and slope) will be estimated from method comparison analysis. |
Countries
United States
Outcome results
None listed