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NCT00219947 Clinical Trial

Viral and Host Factors in the Transmission and Pathogenesis of HIV

HIV Infections Clinical Trial

Official title:
Viral and Host Factors in the Transmission and Pathogenesis of HIV

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00219947
Other study ID # MMA-448
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date July 2000
Est. completion date March 2019

Study information
Verified date April 2019
Source Rockefeller University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Terminated
Enrollment 600
Est. completion date March 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Aaron Diamond AIDS Research Center (ADARC) New York New York
United States Rockefeller University Hospital New York New York

Sponsors (1)
Lead Sponsor Collaborator
Rockefeller University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Participants are tested for HIV-1 RNA levels, the presence of antibodies to HIV antigens, and T cell subsets first visit
Secondary Data will be used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment first visit
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