Observational Study of Blood Treated With Cytolin

Completed

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT01048372

Run by

CytoDyn, Inc.

People needed

20

Starts

2010-01-01

Expected to finish

2012-12-01

Last updated by the study team

2013-05-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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