Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects (THYMON-08001)

This study has been completed.
Sponsor:
Information provided by:
Thymon, LLC
ClinicalTrials.gov Identifier:
NCT00848211
First received: February 13, 2009
Last updated: February 17, 2011
Last verified: February 2011
Results First Received: June 12, 2010  
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: Other: Placebo
Biological: TUTI-16 (0.03mg)
Biological: TUTI-16 (0.1mg)
Biological: TUTI-16 (0.6mg)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1 (0.03mg TUTI-16) Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
Group 2 (0.1mg TUTI-16) Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
Group 3 (0.6mg TUTI-16) Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
Placebo Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84

Participant Flow:   Overall Study
    Group 1 (0.03mg TUTI-16)     Group 2 (0.1mg TUTI-16)     Group 3 (0.6mg TUTI-16)     Placebo  
STARTED     6     7     6     5  
COMPLETED     6     6     5     5  
NOT COMPLETED     0     1     1     0  
Protocol Violation                 0                 1                 1                 0  
Adverse Event                 0                 0                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1 (0.03mg TUTI-16) Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
Group 2 (0.1mg TUTI-16) Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
Group 3 (0.6mg TUTI-16) Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
Placebo Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
Total Total of all reporting groups

Baseline Measures
    Group 1 (0.03mg TUTI-16)     Group 2 (0.1mg TUTI-16)     Group 3 (0.6mg TUTI-16)     Placebo     Total  
Number of Participants  
[units: participants]
  6     7     6     5     24  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     6     7     6     5     24  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  44  ± 10     48  ± 9     41  ± 8     51  ± 5     45.9  ± 8.67  
Gender  
[units: participants]
         
Female     0     0     1     0     1  
Male     6     7     5     5     23  
Region of Enrollment  
[units: participants]
         
United States     6     7     6     5     24  



  Outcome Measures
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1.  Primary:   HIV Viral Load   [ Time Frame: baseline and 20 weeks ]

2.  Primary:   CD4+ T-cell Count   [ Time Frame: baseline and 20 weeks ]

3.  Secondary:   Determination of Anti-Tat Antibodies   [ Time Frame: baseline and 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Gideon Goldstein, MD, PhD
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: Gideon Goldstein, MD, PhD, THYMON, LLC
ClinicalTrials.gov Identifier: NCT00848211     History of Changes
Other Study ID Numbers: THYMON-08001
Study First Received: February 13, 2009
Results First Received: June 12, 2010
Last Updated: February 17, 2011
Health Authority: United States: Food and Drug Administration