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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 11, 2010

Last Updated Date

May 17, 2013

Start Date ^ICMJE

January 2010

Primary Completion Date

January 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01048372 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Observational Study of Blood Treated With Cytolin

Official Title ^ICMJE

An Observational Study to Determine the In-vitro Immunologic and Virology Activity of Cytolin

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Not Provided

Study 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.

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2012

Primary Completion Date

January 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 65 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01048372

Other Study ID Numbers ^ICMJE

2009-P-0023471

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

CytoDyn, Inc.

Study Sponsor ^ICMJE

CytoDyn, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Eric S Rosenberg, MD

Massachusetts General Hospital

PRS Account

CytoDyn, Inc.

Verification Date

May 2013

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

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