Viral and Host Factors in the Transmission and Pathogenes... | NCT00219947

Studies
Viral and Host Factors in the Transmission and Pathogenesis of HIV

NCT00219947

Sponsor

Rockefeller University

Status

Terminated

Last Update Posted

Apr 10, 2019Actual

Enrollment

600Actual

Phase

Not provided

Conditions

HIV Infections

Interventions

blood draw

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Blood drawing protocol for RUH/ADARC. ADARC ceasing operations at RUH

Expanded Access Info

Start Date

Jul 2000

Primary Completion Date

Mar 2019Actual

Completion Date

Mar 2019Actual

First Submitted Date

Sep 20, 2005

First Submission Date that Met QC Criteria

Sep 20, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2019

Last Update Posted Date

Apr 10, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To study the collection of blood from individuals known to be at high risk for HIV-infection or who have been recently infected with HIV.

The data collected are used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment Guidelines.

Detailed Description

This phlebotomy protocol permits the collection of blood from individuals known to be at high risk for HIV-infection or who have been recently infected with HIV.

Participants will have from 10 to 60 ml (approximately 1 to 4 tablespoons) of blood drawn for one or all of the following tests:

T cell subset enumeration
Serologic reactivity with HIV antigens
Viral load assays by bDNA, PCR, or RT-PCR
Routine Laboratory assessments (chemistries, liver function tests, hepatitis serology, RPR)
HIV-1 Resistance Testing

These data are used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment Guidelines

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high risk		Blood draw from individuals known to be or at high risk for HIV-infection	Other: blood draw
diagnosed		Blood draw f rom individuals diagnosed with HIV infection	Other: blood draw

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood draw	Other	T cell subset enumeration Serologic reactivity with HIV antigens Viral load assays by bDNA, PCR, or RT-PCR Routine Laboratory assessments (chemistries, liver function tests, hepatitis serology, RPR) HIV-1 Resistance Testing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participants are tested for HIV-1 RNA levels, the presence of antibodies to HIV antigens, and T cell subsets		first visit

Secondary Outcomes

Measure	Description	Time Frame
Data will be used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment		first visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

recently infected with HIV-1 HIV-1 negative, and at high risk for infection

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects are either referred by primary health care providers, self-referred, or may be seeking enrollment in other ADARC clinical trials in the NYC area.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin M Markowitz, MD	Rockefeller University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aaron Diamond AIDS Research Center (ADARC)		New York	New York	10016	United States
Rockefeller University Hospital

Label	URL
The Aaron Diamond AIDS Research Center	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided