Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
75 participants
OBSERVATIONAL
Brief Summary
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Detailed Description
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The study is divided into two parts.
Part 1 aims to determine the origin of HIV infected naïve T-cells in vivo by assessing the viral relatedness between HIV strains from naïve and memory CD4 T-cells. To do this we will be studying ten chronically infected individuals. Naïve and memory CD4 T-cells from these individuals will be purified using a magnetic bead sorting (MACS) strategy. Envelope sequences will then be isolated and subjected to diversity calculation
Part 2 seeks to answer whether infection of naïve T-cells is established early in infection and what the effect of antiretroviral therapy is on this subset of T-cells. We will initially examine the relative proportion of CD31+ (recent thymic emigrants) and CD31- naive CD4+ T-cells in infected acute (n=15) and chronic (n=15) infection and uninfected (n=15) individuals compared with healthy controls. We will then prospectively test individuals prior to and at 3, 6, 12, 18 and 24 months following intiation of HAART (Highly Active Antiretroviral Therapy) in individuals with acute (n=10) and chronic (n=10) HIV infection. Immunophenotyping will detemine the proportion of naïve T-cells that are CD31+ and those that are CD31-. Naïve and memory T-cell subsets will again be purified and total and integrated HIV DNA will be quantified using real-time PCR.
Conditions
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Keywords
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Study Design
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DEFINED_POPULATION
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Part 1:
\- HIV positive by ELISA and Western Blot VL \>2,000, CD4 \>350
Part 2:
* HIV positive by ELISA and Western Blot
* Established Chronic infection (15 individuals)
* Acute infection (15 individuals).
* Any viral load or CD4 count.
* No therapy.
* Any individual who initiates HAART as determined by the treating physician
Exclusion Criteria
0 Years
ALL
Yes
Sponsors
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Bayside Health
OTHER_GOV
Principal Investigators
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Sharon R Lewin
Role: PRINCIPAL_INVESTIGATOR
Director, Infectious Diseases Unit, The Alfred Hospital
Jenny Hoy
Role: PRINCIPAL_INVESTIGATOR
Head Clinical Research Unit, Infectious Diseases Unit, Alfred Hospital
Locations
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Alfred Hospital
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Sharon R Lewin
Role: primary
Other Identifiers
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114/05
Identifier Type: -
Identifier Source: org_study_id