Clinical trial NCT02026752: Collection of Samples From HIV-1 Infected Individuals for Evaluation of the Aptima HIV-1 Assay
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1 Infection
Lead sponsor: Gen-Probe, Incorporated
Sponsor class: INDUSTRY
First posted: 2014-01-03
Enrollment: 468
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility 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

Primary outcomes:
measure: Quantitative detection of HIV-1 RNA
timeFrame: single baseline visit
Secondary outcomes:
Other outcomes:
Locations:
city: Palm Springs
country: United States
facility: Palmtree Clinical Research Inc
state: California
city: San Diego
country: United States
facility: UCSD - AnitViral Research Center (AVRC)
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Miami
country: United States
facility: University of Miami - AIDS Clinical Research Unit
state: Florida
city: Sarasota
country: United States
facility: Community AIDS Network
state: Florida
city: Indianapolis
country: United States
facility: Wishard Health Services
state: Indiana
city: New Orleans
country: United States
facility: Louisiana State University
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
Study officials:
affiliation: Director
name: Renee Wait
role: STUDY_DIRECTOR
References: