Observational Study of Blood Treated With Cytolin

CytoDyn

Status: Completed

Conditions: HIV Infections

Study type: Observational

Funder types: Industry

Identifiers

NCT01048372

2009-P-0023471

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

20 participants in 2 patient groups

Early HIV infection

Description:

HIV infected adults with early evidence of suppressed cell-mediated immunity but whose disease has not progressed far enough to indicate antiretroviral therapy.

Control

Description:

Healthy adults without HIV infection.