Viral and Host Factors in the Transmission and Pathogenesis of HIV

Study Overview
=================
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

Official Title
-----------------
Viral and Host Factors in the Transmission and Pathogenesis of HIV

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Other: blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recently infected with HIV-1 HIV-1 negative, and at high risk for infection Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| high risk<br>Blood draw from individuals known to be or at high risk for HIV-infection | Other: blood draw<br>* 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<br>|
| diagnosed<br>Blood draw f rom individuals diagnosed with HIV infection | Other: blood draw<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV Infection, Acute HIV Infection, Primary HIV Infection, Acute Seroconversion Syndrome