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Observational Study of Blood Treated With Cytolin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01048372
Recruitment Status : Completed
First Posted : January 13, 2010
Last Update Posted : May 21, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
HIV Infections

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 Design

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study to Determine the In-vitro Immunologic and Virology Activity of Cytolin
Study Start Date : January 2010
Primary Completion Date : January 2011
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Primary Outcome Measures :
  1. T cell number and effector functions in Cytolin-treated blood harvested from HIV infected individuals. [ Time Frame: Entry, 3 months, 6 months ]

Secondary Outcome Measures :
  1. In-vitro suppression of viral replication following Cytolin treatment of blood harvested from HIV infected individuals. [ Time Frame: Entry, 3 months, 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: CytoDyn, Inc.
ClinicalTrials.gov Identifier: NCT01048372     History of Changes
Other Study ID Numbers: 2009-P-0023471
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: May 21, 2013
Last Verified: May 2013

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases