Viral and Host Factors in the Transmission and Pathogenesis of HIV

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2017 by Rockefeller University

Sponsor:

Information provided by (Responsible Party):

Rockefeller University

ClinicalTrials.gov Identifier:

NCT00219947

First received: September 20, 2005

Last updated: January 17, 2017

Last verified: January 2017

History of Changes

Purpose

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	Intervention
HIV Infections	Other: blood draw


Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Viral and Host Factors in the Transmission and Pathogenesis of HIV

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Rockefeller University:

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


Estimated Enrollment:	600
Study Start Date:	July 2000
Estimated Study Completion Date:	July 2019
Estimated Primary Completion Date:	July 2019 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	September 20, 2005
Last Updated:	January 17, 2017
Individual Participant Data
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

ClinicalTrials.gov processed this record on May 25, 2017

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