Viral and Host Factors in the Transmission and Pathogenesis of HIV

Terminated

• Conditions: HIV Infections
• Interventions: Other: blood draw

• Registration Number: NCT00219947
• Lead Sponsor: Rockefeller University

Brief Summary

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

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 Timeline

• Study Start: 2000-07
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-08
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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

Exclusion Criteria

none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
high risk	blood draw	Blood draw from individuals known to be or at high risk for HIV-infection
diagnosed	blood draw	Blood draw f rom individuals diagnosed with HIV infection

Primary Outcome Measures

Name	Time	Method
Participants are tested for HIV-1 RNA levels, the presence of antibodies to HIV antigens, and T cell subsets	first visit

Secondary Outcome Measures

Name	Time	Method
Data will be used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment	first visit

Trial Locations

Locations (2)

Rockefeller University Hospital; 🇺🇸 New York, New York, United States

Aaron Diamond AIDS Research Center (ADARC); 🇺🇸 New York, New York, United States