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Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects (THYMON-11001)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thymon, LLC
ClinicalTrials.gov Identifier:
NCT01335191
First received: April 12, 2011
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
Results First Received: December 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Biological: TUTI-16 (1.0 mg)
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
TUTI-16 (1.0 mg) Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
Placebo Two subcutaneous injections of placebo at Day 0 and Week 3.

Participant Flow:   Overall Study
    TUTI-16 (1.0 mg)     Placebo  
STARTED     16     11  
COMPLETED     16     11  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
TUTI-16 (1.0 mg) Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
Placebo Two subcutaneous injections of placebo at Day 0 and Week 3.
Total Total of all reporting groups

Baseline Measures
    TUTI-16 (1.0 mg)     Placebo     Total  
Number of Participants  
[units: participants]
 		  16     11     27  
Age, Customized  
[units: years]
Mean ( Full Range ) 		     
Between 18 and 65 years     45  
  ( 27 to 55 )   		  43  
  ( 24 to 54 )   		  43  
  ( 24 to 55 )  
Gender  
[units: participants]
 		     
Female     12     2     14  
Male     4     9     13  
Region of Enrollment  
[units: participants]
 		     
United States     16     11     27  



  Outcome Measures

1.  Primary:   Anti-Tat Antibody Titer   [ Time Frame: 54 weeks ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Dr. Gideon Goldstein
Organization: Thymon LLC
phone: (973) 467-9558
e-mail: gidgold@gmail.com


No publications provided by Thymon, LLC

Publications automatically indexed to this study:


Responsible Party: Thymon, LLC
ClinicalTrials.gov Identifier: NCT01335191     History of Changes
Other Study ID Numbers: THYMON-11001
Study First Received: April 12, 2011
Results First Received: December 7, 2012
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration