Viral and Host Factors in the Transmission and Pathogenesis of HIV

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ClinicalTrials.gov Identifier: NCT00219947

Recruitment Status : Recruiting

First Posted : September 22, 2005

Last Update Posted : January 11, 2018

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Rockefeller University

Study Description

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.

Condition or disease	Intervention/treatment
HIV Infections	Other: blood draw

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

Study Design


Study Type :	Observational
Estimated Enrollment :	600 participants
Observational Model:	Other
Time Perspective:	Prospective
Official Title:	Viral and Host Factors in the Transmission and Pathogenesis of HIV
Study Start Date :	July 2000
Estimated Primary Completion Date :	July 2019
Estimated Study Completion Date :	July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
high risk Blood draw from individuals known to be or at high risk for HIV-infection	Other: blood draw 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
diagnosed Blood draw f rom individuals diagnosed with HIV infection	Other: blood draw 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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Biospecimen Retention: Samples With DNA

whole blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219947

Contacts


Contact: Melissa La Mar	212-327-7280	mlamar@rockefeller.edu

Locations


United States, New York
Aaron Diamond AIDS Research Center (ADARC)	Recruiting
New York, New York, United States, 10016
Contact: Melissa La Mar 212-327-7280 mlamar@adarc.org
Rockefeller University Hospital	Recruiting
New York, New York, United States, 10021
Contact: Melissa La Mar 212-327-7280 mlamar@rockefeller.edu

Sponsors and Collaborators

Rockefeller University

Investigators


Principal Investigator:	Martin M Markowitz, MD	Rockefeller University

More Information

Additional Information:

Institutional website listing clinical research protocols and criteria This link exits the ClinicalTrials.gov site

The Aaron Diamond AIDS Research Center This link exits the ClinicalTrials.gov site


Responsible Party:	Rockefeller University
ClinicalTrials.gov Identifier:	NCT00219947 History of Changes
Other Study ID Numbers:	MMA-448
First Posted:	September 22, 2005 Key Record Dates
Last Update Posted:	January 11, 2018
Last Verified:	January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Rockefeller University:


HIV Infection Acute HIV Infection Primary HIV Infection Acute Seroconversion Syndrome

Additional relevant MeSH terms:


Infection HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections	Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases

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