Trial Outcomes & Findings for Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects (NCT NCT00848211)
NCT ID: NCT00848211
Last Updated: 2011-02-24
Results Overview
Change in HIV viral load from baseline
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
baseline and 20 weeks
Results posted on
2011-02-24
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
6
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects
Baseline characteristics by cohort
| Measure |
Group 1 (0.03mg TUTI-16)
n=6 Participants
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
|
Group 2 (0.1mg TUTI-16)
n=7 Participants
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
|
Group 3 (0.6mg TUTI-16)
n=6 Participants
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
|
Placebo
n=5 Participants
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age Continuous
|
44 years
STANDARD_DEVIATION 10 • n=99 Participants
|
48 years
STANDARD_DEVIATION 9 • n=107 Participants
|
41 years
STANDARD_DEVIATION 8 • n=206 Participants
|
51 years
STANDARD_DEVIATION 5 • n=7 Participants
|
45.9 years
STANDARD_DEVIATION 8.67 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
7 participants
n=107 Participants
|
6 participants
n=206 Participants
|
5 participants
n=7 Participants
|
24 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: baseline and 20 weeksChange in HIV viral load from baseline
Outcome measures
| Measure |
Group 1 (0.03mg TUTI-16)
n=6 Participants
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
|
Group 2 (0.1mg TUTI-16)
n=6 Participants
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
|
Group 3 (0.6mg TUTI-16)
n=5 Participants
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
|
Placebo
n=5 Participants
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
|
|---|---|---|---|---|
|
HIV Viral Load
|
-0.18 HIV RNA copies/mL
Standard Error 0.12
|
-0.05 HIV RNA copies/mL
Standard Error 0.13
|
0.002 HIV RNA copies/mL
Standard Error 0.11
|
0.26 HIV RNA copies/mL
Standard Error 0.56
|
PRIMARY outcome
Timeframe: baseline and 20 weeksChange in CD4+ T-cell count from baseline
Outcome measures
| Measure |
Group 1 (0.03mg TUTI-16)
n=6 Participants
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
|
Group 2 (0.1mg TUTI-16)
n=6 Participants
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
|
Group 3 (0.6mg TUTI-16)
n=5 Participants
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
|
Placebo
n=5 Participants
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
|
|---|---|---|---|---|
|
CD4+ T-cell Count
|
-65 cells/mm3
Standard Error 48
|
-116 cells/mm3
Standard Error 56
|
14 cells/mm3
Standard Error 53
|
-59 cells/mm3
Standard Error 22
|
SECONDARY outcome
Timeframe: baseline and 16 weeksDetermination of change in anti-Tat antibody level
Outcome measures
| Measure |
Group 1 (0.03mg TUTI-16)
n=6 Participants
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
|
Group 2 (0.1mg TUTI-16)
n=6 Participants
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
|
Group 3 (0.6mg TUTI-16)
n=5 Participants
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
|
Placebo
n=5 Participants
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
|
|---|---|---|---|---|
|
Determination of Anti-Tat Antibodies
|
20 ng/mL
Interval 20.0 to 456.0
|
84 ng/mL
Interval 20.0 to 181.0
|
84 ng/mL
Interval 20.0 to 642.0
|
20 ng/mL
Interval 20.0 to 53.0
|
Adverse Events
Group 1 (0.03mg TUTI-16)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 2 (0.1mg TUTI-16)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 3 (0.6mg TUTI-16)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 (0.03mg TUTI-16)
n=6 participants at risk
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
|
Group 2 (0.1mg TUTI-16)
n=7 participants at risk
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
|
Group 3 (0.6mg TUTI-16)
n=6 participants at risk
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
|
Placebo
n=5 participants at risk
Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 5
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Injection Site Reaction
|
16.7%
1/6 • Number of events 1
|
42.9%
3/7 • Number of events 3
|
50.0%
3/6 • Number of events 8
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
16.7%
1/6 • Number of events 1
|
14.3%
1/7 • Number of events 2
|
33.3%
2/6 • Number of events 4
|
40.0%
2/5 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
muscular weakness
|
33.3%
2/6 • Number of events 7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place