Observational Study of Blood Treated With Cytolin

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01048372

Enrollment

Registered

2010-01-13

Start date

2010-01-31

Completion date

2012-12-31

Last updated

2013-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, monoclonal antibody, immune therapy, pathogenesis, cytotoxic T lymphocyte, anti-CD4, anti-self, viral replication, Acute Infection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results