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

January 11, 2010
May 17, 2013
January 2010
January 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01048372 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Observational Study of Blood Treated With Cytolin
An Observational Study to Determine the In-vitro Immunologic and Virology Activity of Cytolin

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

HIV Infections
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2012
January 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01048372
2009-P-0023471
No
CytoDyn, Inc.
CytoDyn, Inc.
Not Provided
Principal Investigator: Eric S Rosenberg, MD Massachusetts General Hospital
CytoDyn, Inc.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP