Observational Study of Blood Treated With Cytolin

Tracking Information
First Submitted Date	January 11, 2010
First Posted Date	January 13, 2010
Last Update Posted Date	May 21, 2013
Study Start Date	January 2010
Actual Primary Completion Date	January 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: January 11, 2010)	T cell number and effector functions in Cytolin-treated blood harvested from HIV infected individuals. [ Time Frame: Entry, 3 months, 6 months ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01048372 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: January 11, 2010)	In-vitro suppression of viral replication following Cytolin treatment of blood harvested from HIV infected individuals. [ Time Frame: Entry, 3 months, 6 months ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Observational Study of Blood Treated With Cytolin
Official Title	An Observational Study to Determine the In-vitro Immunologic and Virology Activity of Cytolin
Brief Summary	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	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.
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Adult human subjects willing and able to have blood drawn at Massachusetts General Hospital in Boston, MA at baseline, three months and six months. All healthy volunteers have been enrolled and enrollment is now open only to subjects with earlyh HIV infection.
Condition	HIV Infections
Intervention	Not Provided
Study Groups/Cohorts	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.; Control Healthy adults without HIV infection.
Publications *	Zarling JM, Ledbetter JA, Sias J, Fultz P, Eichberg J, Gjerset G, Moran PA. HIV-infected humans, but not chimpanzees, have circulating cytotoxic T lymphocytes that lyse uninfected CD4+ cells. J Immunol. 1990 Apr 15;144(8):2992-8.; Morimoto C, Rudd CE, Letvin NL, Schlossman SF. A novel epitope of the LFA-1 antigen which can distinguish killer effector and suppressor cells in human CD8 cells. Nature. 1987 Dec 3-9;330(6147):479-82.; Cavallin F, Traldi A, Zambello R. Phenotypical and functional evaluation of CD8+/S6F1+ T lymphocytes in haemophiliac individuals with HIV-1 infection. Clin Exp Immunol. 1993 Jul;93(1):51-5.; Tsubota H, Lord CI, Watkins DI, Morimoto C, Letvin NL. A cytotoxic T lymphocyte inhibits acquired immunodeficiency syndrome virus replication in peripheral blood lymphocytes. J Exp Med. 1989 Apr 1;169(4):1421-34.; Allen AD, Hart DN, Hechinger MK, Slattery MJ, Chesson CV 2nd, Vidikan P. Leukocyte adhesion molecules as a cofactor in AIDS: basic science and pilot study. Med Hypotheses. 1995 Aug;45(2):164-8.; Allen AD, Hillis T, Vidikan P, Beer V. Pitfalls in the use of surrogate markers for human immunodeficiency virus disease: further evidence on pathogenesis. Med Hypotheses. 1996 Jul;47(1):27-30.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: January 11, 2010)	20
Original Estimated Enrollment	Same as current
Actual Study Completion Date	December 2012
Actual Primary Completion Date	January 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT01048372
Other Study ID Numbers	2009-P-0023471
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	CytoDyn, Inc.
Study Sponsor	CytoDyn, Inc.
Collaborators	Not Provided
Investigators	Principal Investigator: Eric S Rosenberg, MD Massachusetts General Hospital
PRS Account	CytoDyn, Inc.
Verification Date	May 2013