Viral and Host Factors in the Transmission and Pathogenesis of HIV

April 8, 2019 updated by: Rockefeller University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Rockefeller University Hospital
      • New York, New York, United States, 10016
        • Aaron Diamond AIDS Research Center (ADARC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rockefeller University

Investigators

  • Principal Investigator: Martin M Markowitz, MD, Rockefeller University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2000

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

September 20, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMA-448

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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