Observational Study of Blood Treated With Cytolin

NCT01048372 | Completed

• 1 other identifier: 2009-P-0023471
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV; monoclonal antibody; immune therapy; pathogenesis; cytotoxic T lymphocyte; anti-CD4; anti-self; viral replication; Acute Infection

Outcome Measures

Primary Outcomes (1)

• T cell number and effector functions in Cytolin-treated blood harvested from HIV infected individuals.

  Entry, 3 months, 6 months

Secondary Outcomes (1)

• In-vitro suppression of viral replication following Cytolin treatment of blood harvested from HIV infected individuals.

  Entry, 3 months, 6 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• HIV seropositive
• viral load \< 100,000 copies/ml
• CD4+ \> 350 cells/ul
• Ability and willingness to give written informed consent.
• Control Group
• HIV seronegative subjects identified as HIV uninfected by a nonreactive HIV 1/2 ELISA.
• Ability and willingness to give written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CytoDyn, Inc.: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (6)

• 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.

  PMID: 1969880 BACKGROUND

• 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.

  PMID: 2446140 BACKGROUND

• 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.

  PMID: 8324903 BACKGROUND

• 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.

  PMID: 2784486 BACKGROUND

• 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.

  PMID: 8531839 BACKGROUND

• 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.

  PMID: 8819112 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Eric S Rosenberg, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 13, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: December 1, 2012
• Last Updated: May 21, 2013

Record last verified: 2013-05

Locations

US (1)