Observational Study of Blood Treated With Cytolin
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||An Observational Study to Determine the In-vitro Immunologic and Virology Activity of Cytolin|
- T cell number and effector functions in Cytolin-treated blood harvested from HIV infected individuals. [ Time Frame: Entry, 3 months, 6 months ] [ Designated as safety issue: No ]
- In-vitro suppression of viral replication following Cytolin treatment of blood harvested from HIV infected individuals. [ Time Frame: Entry, 3 months, 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Study Completion Date:||December 2012|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Early HIV infection
HIV infected adults with early evidence of suppressed cell-mediated immunity but whose disease has not progressed far enough to indicate antiretroviral therapy.
Healthy adults without HIV infection.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01048372
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Eric S Rosenberg, MD||Massachusetts General Hospital|