Observational Study of Blood Treated With Cytolin

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048372
• Other study ID #: 2009-P-0023471
• Status: Completed
• Phase: N/A
• First received: January 11, 2010
• Last updated: May 17, 2013
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: CytoDyn, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
CytoDyn, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T cell number and effector functions in Cytolin-treated blood harvested from HIV infected individuals.		Entry, 3 months, 6 months	No
Secondary	In-vitro suppression of viral replication following Cytolin treatment of blood harvested from HIV infected individuals.		Entry, 3 months, 6 months	No