NCT02026752

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
468

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

9 active sites

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

December 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.1 years

First QC Date

December 31, 2013

Last Update Submit

February 22, 2017

Conditions

HIV-1 Infection

Outcome Measures

Primary Outcomes (1)

  • Quantitative detection of HIV-1 RNA

    Regression parameters (intercept and slope) will be estimated from method comparison analysis.

    single baseline visit

Study Arms (1)

Study Population

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Palmtree Clinical Research Inc

Palm Springs, California, 92262, United States

Location

UCSD - AnitViral Research Center (AVRC)

San Diego, California, 92103, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

University of Miami - AIDS Clinical Research Unit

Miami, Florida, 33136, United States

Location

Community AIDS Network

Sarasota, Florida, 34237, United States

Location

Wishard Health Services

Indianapolis, Indiana, 46202, United States

Location

Louisiana State University

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma

Study Officials

  • Renee Wait

    Director

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 31, 2013

First Posted

January 3, 2014

Study Start

January 1, 2014

Primary Completion

February 1, 2015

Study Completion

January 1, 2017

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

US(9)