Viral and Host Factors in the Transmission and Pathogenesis of HIV

NCT ID: NCT00219947

Last Updated: 2019-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-07-31

Study Completion Date

2019-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

high risk

Blood draw from individuals known to be or at high risk for HIV-infection

blood draw

Intervention Type OTHER

* 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

blood draw

Intervention Type OTHER

* 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

none
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rockefeller University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martin M Markowitz, MD

Role: PRINCIPAL_INVESTIGATOR

Rockefeller University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aaron Diamond AIDS Research Center (ADARC)

New York, New York, United States

Site Status

Rockefeller University Hospital

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.adarc.org

The Aaron Diamond AIDS Research Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MMA-448

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.