Trial Outcomes & Findings for Combination Vaccination Before HIV Treatment Interruption (NCT NCT00212888)
NCT ID: NCT00212888
Last Updated: 2019-06-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Up to week 48
Results posted on
2019-06-17
Participant Flow
Participant milestones
| Measure |
ALVAC With Remune
Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
ALVAC With Remune Placebo
Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
Both Placebos
Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
15
|
|
Overall Study
COMPLETED
|
16
|
18
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Vaccination Before HIV Treatment Interruption
Baseline characteristics by cohort
| Measure |
ALVAC With Remune
n=19 Participants
Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
ALVAC With Remune Placebo
n=18 Participants
Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
Both Placebos
n=15 Participants
Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.7 years
n=5 Participants
|
41.5 years
n=7 Participants
|
43.4 years
n=5 Participants
|
41.8 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Duration on ART
|
3.61 years
n=5 Participants
|
5.15 years
n=7 Participants
|
5.18 years
n=5 Participants
|
4.89 years
n=4 Participants
|
|
Baseline CD4 cell count
|
771 cells/ul
n=5 Participants
|
658 cells/ul
n=7 Participants
|
848 cells/ul
n=5 Participants
|
768 cells/ul
n=4 Participants
|
|
Baseline CD4%
|
37.1 percent
n=5 Participants
|
38.0 percent
n=7 Participants
|
35.0 percent
n=5 Participants
|
37.2 percent
n=4 Participants
|
|
CD4 nadir
|
347 cells/ul
n=5 Participants
|
326 cells/ul
n=7 Participants
|
368 cells/ul
n=5 Participants
|
353 cells/ul
n=4 Participants
|
|
Pre-HAART HIV-RNA
|
4.4 log 10 (copies/ml)
n=5 Participants
|
4.0 log 10 (copies/ml)
n=7 Participants
|
4.2 log 10 (copies/ml)
n=5 Participants
|
4.1 log 10 (copies/ml)
n=4 Participants
|
|
Presence of 'protective' HLA allele
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
9 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to week 48Outcome measures
| Measure |
ALVAC With Remune
n=16 Participants
Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
Both Placebos
n=14 Participants
Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
Both Placebos
Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
|---|---|---|---|
|
Time to Detectable Virus in the Remune Plus ALVAC Group and the Placebo Group
|
24.5 days
Interval 11.0 to 32.0
|
13.5 days
Interval 11.0 to 25.0
|
—
|
SECONDARY outcome
Timeframe: Up to week 48Outcome measures
| Measure |
ALVAC With Remune
n=18 Participants
Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
Both Placebos
n=14 Participants
Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
Both Placebos
Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
|---|---|---|---|
|
Time to Detectable Virus in the ALVAC Alone Group and the Placebo Group
|
23.0 days
Interval 16.0 to 31.0
|
13.5 days
Interval 11.0 to 25.0
|
—
|
SECONDARY outcome
Timeframe: Up to week 48Population: Only participants who reached 10,000 copies/ml are included in the analysis.
Outcome measures
| Measure |
ALVAC With Remune
n=13 Participants
Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
Both Placebos
n=15 Participants
Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
Both Placebos
n=12 Participants
Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
|---|---|---|---|
|
Time to Rebound of Plasma HIV RNA Level to 10,000 Copies/ml
|
30.0 days
Interval 18.0 to 44.0
|
31.0 days
Interval 25.0 to 37.0
|
24.5 days
Interval 21.0 to 30.0
|
SECONDARY outcome
Timeframe: Up to week 48Population: Only participants whose viral loads reached a steady state are included in the analysis.
Viral set-point is the viral load (HIV RNA) that the body settles at within a few weeks to months after infection with HIV.
Outcome measures
| Measure |
ALVAC With Remune
n=14 Participants
Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
Both Placebos
n=17 Participants
Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
Both Placebos
n=12 Participants
Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
|---|---|---|---|
|
Viral Set-point
|
4.4 log10 copies/ml
Interval 3.4 to 4.7
|
4.2 log10 copies/ml
Interval 3.8 to 4.4
|
4.5 log10 copies/ml
Interval 3.8 to 5.2
|
SECONDARY outcome
Timeframe: Up to week 48Magnitude of viral rebound is the amount of HIV viral load an infected person who was previously on ART and suppressed below clinical detection rebounds to following ART stoppage. This will typically be compared to the viral load before starting ART or Viral set-point discussed earlier.
Outcome measures
| Measure |
ALVAC With Remune
n=16 Participants
Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
Both Placebos
n=18 Participants
Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
Both Placebos
n=14 Participants
Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
|---|---|---|---|
|
Magnitude of Viral Rebound
|
4.8 log10 copies/ml
Interval 4.2 to 5.2
|
5.0 log10 copies/ml
Interval 4.3 to 5.4
|
5.0 log10 copies/ml
Interval 4.6 to 5.6
|
SECONDARY outcome
Timeframe: at week 48Population: Data not collected for this assessment.
Outcome measures
Outcome data not reported
Adverse Events
ALVAC With Remune
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
ALVAC With Remune Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Both Placebos
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 |
ALVAC With Remune
n=19 participants at risk
Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
ALVAC With Remune Placebo
n=18 participants at risk
Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
Both Placebos
n=15 participants at risk
Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
36.8%
7/19
|
50.0%
9/18
|
20.0%
3/15
|
|
General disorders
Subjective fever
|
26.3%
5/19
|
5.6%
1/18
|
6.7%
1/15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place