Clinical trial NCT01048372: Observational Study of Blood Treated With Cytolin
Official title: An Observational Study to Determine the In-vitro Immunologic and Virology Activity of Cytolin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV
monoclonal antibody
immune therapy
pathogenesis
cytotoxic T lymphocyte
anti-CD4
anti-self
viral replication
Acute Infection
Lead sponsor: CytoDyn, Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: T cell number and effector functions in Cytolin-treated blood harvested from HIV infected individuals.
timeFrame: Entry, 3 months, 6 months
Secondary outcomes:
measure: In-vitro suppression of viral replication following Cytolin treatment of blood harvested from HIV infected individuals.
timeFrame: Entry, 3 months, 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Eric S Rosenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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. doi: 10.1038/330479a0.
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. doi: 10.1111/j.1365-2249.1993.tb06496.x.
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. doi: 10.1084/jem.169.4.1421.
citation: 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. doi: 10.1016/0306-9877(95)90065-9.
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. doi: 10.1016/s0306-9877(96)90038-9.