Observational Study of Blood Treated With Cytolin
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ClinicalTrials.gov Identifier: NCT01048372 |
Recruitment Status
:
Completed
First Posted
: January 13, 2010
Last Update Posted
: May 21, 2013
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Sponsor:
CytoDyn, Inc.
Information provided by (Responsible Party):
CytoDyn, Inc.
Tracking Information | ||||
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First Submitted Date | January 11, 2010 | |||
First Posted Date | January 13, 2010 | |||
Last Update Posted Date | May 21, 2013 | |||
Study Start Date | January 2010 | |||
Actual Primary Completion Date | January 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
T cell number and effector functions in Cytolin-treated blood harvested from HIV infected individuals. [ Time Frame: Entry, 3 months, 6 months ] | |||
Original Primary Outcome Measures | Same as current | |||
Change History | Complete list of historical versions of study NCT01048372 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
In-vitro suppression of viral replication following Cytolin treatment of blood harvested from HIV infected individuals. [ Time Frame: Entry, 3 months, 6 months ] | |||
Original Secondary Outcome Measures | Same as current | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Observational Study of Blood Treated With Cytolin | |||
Official Title | An Observational Study to Determine the In-vitro Immunologic and Virology Activity of Cytolin | |||
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 Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Adult human subjects willing and able to have blood drawn at Massachusetts General Hospital in Boston, MA at baseline, three months and six months. All healthy volunteers have been enrolled and enrollment is now open only to subjects with earlyh HIV infection. | |||
Condition | HIV Infections | |||
Intervention | Not Provided | |||
Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
20 | |||
Original Estimated Enrollment | Same as current | |||
Actual Study Completion Date | December 2012 | |||
Actual Primary Completion Date | January 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Early HIV Infection Inclusion Criteria:
Control Group Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01048372 | |||
Other Study ID Numbers | 2009-P-0023471 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | CytoDyn, Inc. | |||
Study Sponsor | CytoDyn, Inc. | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | CytoDyn, Inc. | |||
Verification Date | May 2013 |