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Viral and Host Factors in the Transmission and Pathogenesis of HIV

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Rockefeller University
Sponsor:
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00219947
First received: September 20, 2005
Last updated: November 4, 2014
Last verified: November 2014
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Data will be used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment [ Time Frame: first visit ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood
Estimated Enrollment: 600
Study Start Date: July 2000
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (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
Genders Eligible for Study:   Both
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:

none

  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 Recruiting
New York, New York, United States, 10016
Contact: Don Garmon    212-327-7290      
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:
The Aaron Diamond AIDS Research Center  This link exits the ClinicalTrials.gov site

No publications provided

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: November 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rockefeller University:
HIV Infection
Acute HIV Infection
Primary HIV Infection
Acute Seroconversion Syndrome

ClinicalTrials.gov processed this record on March 03, 2015