NCT02461576

Brief Summary

Compare the clinical performance of the Xpert® HIV-1 VL to another FDA approved HIV-1 RNA quantitative assay using frozen and fresh specimens from known HIV-1 positive individuals.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
966

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
28 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2017

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

1.7 years

First QC Date

May 26, 2015

Last Update Submit

February 2, 2018

Conditions

Human Immunodeficiency Virus

Keywords

HIV-1

Outcome Measures

Primary Outcomes (1)

  • Quantification of HIV-1 RNA in copies/mL in known HIV-1 positive subjects

    This study is a comparative analysis of HIV-1 RNA quantitation between Xpert HIV-1 VL to another FDA approved test. A single time point (cross-sectional) from each of at least 300 subjects with HIV-1 RNA quantitation within the dynamic range of both assays will be used in regression models to assess performance of the Xpert HIV-1 VL in comparison to the other FDA approved test.

    1 day (A single time point)

Study Arms (1)

HIV-1 infected

this is a study comparing Xpert HIV-1 VL assay quantitation to an already FDA approved HIV-1 quantitative HIV-1 RNA assay in known HIV-1 infected individuals

Device: Xpert HIV-1 VL Assay

Interventions

Xpert HIV-1 VL AssayDEVICE

in vitro diagnostic test to quantify HIV-1 RNA

HIV-1 infected

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Males and females \>18 yours who are known HIV-1 infected and may be on treatment or untreated with ARV therapy

You may qualify if:

  • HIV-1 seropositive adults using an FDA approved method
  • At least 18 years of age or older
  • Informed consent, if applicable

You may not qualify if:

  • Subject is less than 18 years of age
  • Previously enrolled in this study
  • Samples not collected according to the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Leftover plasma specimens will be retained in a biobank.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2015

First Posted

June 3, 2015

Study Start

July 1, 2015

Primary Completion

February 24, 2017

Study Completion

February 24, 2017

Last Updated

February 6, 2018

Record last verified: 2018-02