Trial Outcomes & Findings for Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects (NCT NCT01144026)
NCT ID: NCT01144026
Last Updated: 2013-01-18
Results Overview
ELISA based chemiluminescent assay to determine the anti-Tat antibody response
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
5 weeks
Results posted on
2013-01-18
Participant Flow
Participant milestones
| Measure |
TUTI-16 (0.2mg)
Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
|
TUTI-16 (1.0 mg)
Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
|
Overall Study
COMPLETED
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects
Baseline characteristics by cohort
| Measure |
TUTI-16 (0.2mg)
n=10 Participants
Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
|
TUTI-16 (1.0 mg)
n=5 Participants
Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
|
Total
n=15 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
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age Continuous
|
38.4 years
STANDARD_DEVIATION 8.51 • n=99 Participants
|
36.4 years
STANDARD_DEVIATION 4.56 • n=107 Participants
|
38.4 years
STANDARD_DEVIATION 7.64 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
5 participants
n=107 Participants
|
15 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 5 weeksPopulation: all participants enrolled were analyzed
ELISA based chemiluminescent assay to determine the anti-Tat antibody response
Outcome measures
| Measure |
TUTI-16 (0.2mg)
n=10 Participants
Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
|
TUTI-16 (1.0 mg)
n=5 Participants
Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
|
|---|---|---|
|
Anti-Tat Antibody Titer
|
401 ng/mL
Interval 0.0 to 2565.0
|
887 ng/mL
Interval 99.0 to 2286.0
|
Adverse Events
TUTI-16 (0.2mg)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
TUTI-16 (1.0 mg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TUTI-16 (0.2mg)
n=10 participants at risk
Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
|
TUTI-16 (1.0 mg)
n=5 participants at risk
Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
|
|---|---|---|
|
General disorders
injection site reaction
|
40.0%
4/10 • Number of events 9
|
20.0%
1/5 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place