Observational Study of Blood Treated With Cytolin

Completed

• Conditions: HIV Infections

• Registration Number: NCT01048372
• Lead Sponsor: CytoDyn, Inc.

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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-11
• Study First Posted: 2010-01-13
• Primary Completion: 2011-01
• Study Completion: 2012-12
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-17
• Last Update Posted: 2013-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
T cell number and effector functions in Cytolin-treated blood harvested from HIV infected individuals.	Entry, 3 months, 6 months

Secondary Outcome Measures

Name	Time	Method
In-vitro suppression of viral replication following Cytolin treatment of blood harvested from HIV infected individuals.	Entry, 3 months, 6 months

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States