Observational Study of Blood Treated With Cytolin

Study Overview
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Brief Summary
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Primary Objective: To determine the mechanism of Cytolin's effect on HIV replication from blood drawn from HIV-positive and HIV-negative individuals after exposure to Cytolin.

Detailed Description
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The initial phase of this in vitro study regarding the potential mechanisms of action of Cytolin was completed in January 2011. Given the data set to date, a decision has been made to extend the study. The extension will allow the Company to further confirm and extend the initial findings regarding the potential mechanism of action of Cytolin.

Official Title
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An Observational Study to Determine the In-vitro Immunologic and Virology Activity of Cytolin

Conditions
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HIV Infections

Participation Criteria
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Eligibility Criteria
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Early HIV Infection Inclusion Criteria: HIV seropositive viral load < 100,000 copies/ml CD4+ > 350 cells/ul Ability and willingness to give written informed consent. Control Group Inclusion Criteria: HIV seronegative subjects identified as HIV uninfected by a nonreactive HIV 1/2 ELISA. Ability and willingness to give written informed consent. Exclusion Criteria: Presentation with an opportunistic infection or AIDS-defining illness. Receipt of investigational research agent within 30 days prior to study entry. Prior receipt of experimental HIV vaccine, sham vector or adjuvant. Receipt of immunosuppressive medications or immune modulators within the past six months. Individuals taking corticosteroid nasal spray for allergic rhinitis, topical steroid or over the counter medications for acute, uncomplicated dermatitis for a period no longer than 14 days will not be excluded. Active drug or alcohol use, dependence or psychiatric illness that in the opinion of the study investigator would interfere with adherence to study protocol. Serious illness requiring hospitalization.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early HIV infection<br>HIV infected adults with early evidence of suppressed cell-mediated immunity but whose disease has not progressed far enough to indicate antiretroviral therapy. | |
| Control<br>Healthy adults without HIV infection. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T cell number and effector functions in Cytolin-treated blood harvested from HIV infected individuals. |  | Entry, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-vitro suppression of viral replication following Cytolin treatment of blood harvested from HIV infected individuals. |  | Entry, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, monoclonal antibody, immune therapy, pathogenesis, cytotoxic T lymphocyte, anti-CD4, anti-self, viral replication, Acute Infection