Observational Study of Blood Treated With Cytolin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CytoDyn, Inc.
ClinicalTrials.gov Identifier:
NCT01048372
First received: January 11, 2010
Last updated: May 17, 2013
Last verified: May 2013
  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:


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 ]

Enrollment: 20
Study Start Date: January 2010
Study Completion Date: December 2012
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: CytoDyn, Inc.
ClinicalTrials.gov Identifier: NCT01048372     History of Changes
Other Study ID Numbers: 2009-P-0023471
Study First Received: January 11, 2010
Last Updated: May 17, 2013
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 July 26, 2014