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

22. februar 2017 oppdatert av: Gen-Probe, Incorporated

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

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.

Studieoversikt

Status

Fullført

Forhold

HIV-1 infeksjon

Studietype

Observasjonsmessig

Registrering (Faktiske)

468

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- California
  - Palm Springs, California, Forente stater, 92262
    - Palmtree Clinical research Inc
  - San Diego, California, Forente stater, 92103
    - UCSD - AnitViral Research Center (AVRC)
- Connecticut
  - New Haven, Connecticut, Forente stater, 06510
    - Yale University
- Florida
  - Miami, Florida, Forente stater, 33136
    - University of Miami - AIDS Clinical Research Unit
  - Sarasota, Florida, Forente stater, 34237
    - Community AIDS Network
- Indiana
  - Indianapolis, Indiana, Forente stater, 46202
    - Wishard Health Services
- Louisiana
  - New Orleans, Louisiana, Forente stater, 70112
    - Louisiana State University
- Maryland
  - Baltimore, Maryland, Forente stater, 21287
    - Johns Hopkins University
- New York
  - Bronx, New York, Forente stater, 10461
    - Jacobi Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

15 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: Kohort
Tidsperspektiver: Tverrsnitt

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
Studiepopulasjon

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Quantitative detection of HIV-1 RNA Tidsramme: single baseline visit	Regression parameters (intercept and slope) will be estimated from method comparison analysis.	single baseline visit

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Gen-Probe, Incorporated

Etterforskere

Studieleder: Renee Wait, Director

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2014

Primær fullføring (Faktiske)

1. februar 2015

Studiet fullført (Faktiske)

1. januar 2017

Datoer for studieregistrering

Først innsendt

31. desember 2013

Først innsendt som oppfylte QC-kriteriene