Trial Outcomes & Findings for Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects (THYMON-11001) (NCT NCT01335191)
NCT ID: NCT01335191
Last Updated: 2013-02-15
Results Overview
ELISA based chemiluminescent assay to determine the anti-Tat antibody response
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
54 weeks
Results posted on
2013-02-15
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
11
|
|
Overall Study
COMPLETED
|
16
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects (THYMON-11001)
Baseline characteristics by cohort
| Measure |
TUTI-16 (1.0 mg)
n=16 Participants
Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
|
Placebo
n=11 Participants
Two subcutaneous injections of placebo at Day 0 and Week 3.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Between 18 and 65 years
|
45 years
n=5 Participants
|
43 years
n=7 Participants
|
43 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
11 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 54 weeksPopulation: all subjects enrolled
ELISA based chemiluminescent assay to determine the anti-Tat antibody response
Outcome measures
| Measure |
TUTI-16 (1.0 mg)
n=16 Participants
Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
|
Placebo
n=11 Participants
Two subcutaneous injections of placebo at Day 0 and Week 3.
|
|---|---|---|
|
Anti-Tat Antibody Titer
|
698 ng/mL
Interval 0.0 to 3000.0
|
4 ng/mL
Interval 0.0 to 42.0
|
Adverse Events
TUTI-16 (1.0 mg)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
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 (1.0 mg)
n=16 participants at risk
Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
|
Placebo
n=11 participants at risk
Two subcutaneous injections of placebo at Day 0 and Week 3.
|
|---|---|---|
|
General disorders
injection site reaction
|
50.0%
8/16 • Number of events 13
|
9.1%
1/11 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place