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

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ClinicalTrials.gov Identifier: NCT00848211
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : February 21, 2011
Last Update Posted : February 24, 2011
Sponsor:
Information provided by:
Thymon, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, 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)
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 (0.03mg TUTI-16) Group 2 (0.1mg TUTI-16) Group 3 (0.6mg TUTI-16) Placebo
Hide Arm/Group Description Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
Period Title: Overall Study
Started 6 7 6 5
Completed 6 6 5 5
Not Completed 0 1 1 0
Reason Not Completed
Protocol Violation             0             1             1             0
Adverse Event             0             0             0             0
Arm/Group Title Group 1 (0.03mg TUTI-16) Group 2 (0.1mg TUTI-16) Group 3 (0.6mg TUTI-16) Placebo Total
Hide Arm/Group Description Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 Total of all reporting groups
Overall Number of Baseline Participants 6 7 6 5 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 7 participants 6 participants 5 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
7
 100.0%
6
 100.0%
5
 100.0%
24
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 7 participants 6 participants 5 participants 24 participants
44  (10) 48  (9) 41  (8) 51  (5) 45.9  (8.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 7 participants 6 participants 5 participants 24 participants
Female
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
1
   4.2%
Male
6
 100.0%
7
 100.0%
5
  83.3%
5
 100.0%
23
  95.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 7 participants 6 participants 5 participants 24 participants
6 7 6 5 24
1.Primary Outcome
Title HIV Viral Load
Hide Description Change in HIV viral load from baseline
Time Frame baseline and 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 (0.03mg TUTI-16) Group 2 (0.1mg TUTI-16) Group 3 (0.6mg TUTI-16) Placebo
Hide Arm/Group Description:
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
Overall Number of Participants Analyzed 6 6 5 5
Log Mean (Standard Error)
Unit of Measure: HIV RNA copies/mL
-0.18  (0.12) -0.05  (0.13) 0.002  (0.11) 0.26  (0.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 (0.03mg TUTI-16), Group 2 (0.1mg TUTI-16), Group 3 (0.6mg TUTI-16), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title CD4+ T-cell Count
Hide Description Change in CD4+ T-cell count from baseline
Time Frame baseline and 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 (0.03mg TUTI-16) Group 2 (0.1mg TUTI-16) Group 3 (0.6mg TUTI-16) Placebo
Hide Arm/Group Description:
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
Overall Number of Participants Analyzed 6 6 5 5
Log Mean (Standard Error)
Unit of Measure: cells/mm3
-65  (48) -116  (56) 14  (53) -59  (22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 (0.03mg TUTI-16), Group 2 (0.1mg TUTI-16), Group 3 (0.6mg TUTI-16), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Determination of Anti-Tat Antibodies
Hide Description Determination of change in anti-Tat antibody level
Time Frame baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 (0.03mg TUTI-16) Group 2 (0.1mg TUTI-16) Group 3 (0.6mg TUTI-16) Placebo
Hide Arm/Group Description:
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
Overall Number of Participants Analyzed 6 6 5 5
Median (Full Range)
Unit of Measure: ng/mL
20
(20 to 456)
84
(20 to 181)
84
(20 to 642)
20
(20 to 53)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 (0.03mg TUTI-16) Group 2 (0.1mg TUTI-16) Group 3 (0.6mg TUTI-16) Placebo
Hide Arm/Group Description Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
All-Cause Mortality
Group 1 (0.03mg TUTI-16) Group 2 (0.1mg TUTI-16) Group 3 (0.6mg TUTI-16) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 (0.03mg TUTI-16) Group 2 (0.1mg TUTI-16) Group 3 (0.6mg TUTI-16) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/7 (0.00%)      0/6 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1 (0.03mg TUTI-16) Group 2 (0.1mg TUTI-16) Group 3 (0.6mg TUTI-16) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/6 (83.33%)      5/7 (71.43%)      5/6 (83.33%)      4/5 (80.00%)    
Gastrointestinal disorders         
Gastrointestinal disorder  1 [1]  1/6 (16.67%)  1 1/7 (14.29%)  2 2/6 (33.33%)  4 2/5 (40.00%)  2
General disorders         
Injection Site Reaction  1 [2]  1/6 (16.67%)  1 3/7 (42.86%)  3 3/6 (50.00%)  8 1/5 (20.00%)  1
Musculoskeletal and connective tissue disorders         
muscular weakness  1 [3]  2/6 (33.33%)  7 1/7 (14.29%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0
Nervous system disorders         
Headache  1  1/6 (16.67%)  5 0/7 (0.00%)  0 1/6 (16.67%)  1 1/5 (20.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[1]
nausea, vomitting, diarrhea, abdominal pain upper
[2]
Injection site tenderness, irritation, erythema, pain, induration, swelling
[3]
fatigue, myalgia, muscular weakness, arthralgia,
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
Responsible Party: Gideon Goldstein, MD, PhD, THYMON, LLC
ClinicalTrials.gov Identifier: NCT00848211     History of Changes
Other Study ID Numbers: THYMON-08001
First Submitted: February 13, 2009
First Posted: February 20, 2009
Results First Submitted: June 12, 2010
Results First Posted: February 21, 2011
Last Update Posted: February 24, 2011