Observational Study of Blood Treated With Cytolin - Full Text View

Purpose

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.

Condition
HIV Infections

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	An Observational Study to Determine the In-vitro Immunologic and Virology Activity of Cytolin

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by CytoDyn, Inc.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	20
Study Start Date:	January 2010
Estimated Study Completion Date:	January 2013
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01048372

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

CytoDyn, Inc.

Investigators

Principal Investigator:

Eric S Rosenberg, MD

Massachusetts General Hospital

More Information

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.

Responsible Party:	Eric Rosenberg, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01048372 History of Changes
Other Study ID Numbers:	2009-P-0023471
Study First Received:	January 11, 2010
Last Updated:	June 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by CytoDyn, Inc.:

HIV
monoclonal antibody
immune therapy
pathogenesis
cytotoxic T lymphocyte

anti-CD4
anti-self
viral replication
Acute Infection

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013