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Completed

NCT Number: NCT01048372

Observational Study of Blood Treated With Cytolin

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. T cell number and effector functions in Cytolin-treated blood harvested from HIV infected individuals.

    Time frame: Entry, 3 months, 6 months

Secondary outcomes

  1. In-vitro suppression of viral replication following Cytolin treatment of blood harvested from HIV infected individuals.

    Time frame: Entry, 3 months, 6 months

Sponsors and collaborators

Lead sponsor

CytoDyn, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jan 13, 2010
Registry last updated
May 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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