We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Viral and Host Factors in the Transmission and Pathogenesis of HIV

This study is currently recruiting participants.
Verified January 2017 by Rockefeller University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00219947
First Posted: September 22, 2005
Last Update Posted: January 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Rockefeller University
  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:


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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:
Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00219947     History of Changes
Other Study ID Numbers: MMA-448
First Submitted: September 20, 2005
First Posted: September 22, 2005
Last Update Posted: January 19, 2017
Last Verified: January 2017
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