Trial Outcomes & Findings for Follow up of Thai Adult Volunteers With Breakthrough HIV Infection After Participation in a Preventive HIV Vaccine Trial (NCT NCT00337181)
NCT ID: NCT00337181
Last Updated: 2018-08-22
Results Overview
Evaluate the vaccine effect on clinical long term endpoints: CD4 is for CD4\<350 endpoint; ART is for initiation of highly-active antiretroviral therapy (HAART) endpoint; ADI is for AIDS-defining illness endpoint; A combination of multiple endpoints is listed in order of occurrences of the endpoints
Recruitment status
COMPLETED
Target enrollment
114 participants
Primary outcome timeframe
66 months
Results posted on
2018-08-22
Participant Flow
Participant milestones
| Measure |
Vaccine Group
Received vaccination in RV144
|
Placebo Group
Received placebo in RV144
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
65
|
|
Overall Study
COMPLETED
|
49
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Follow up of Thai Adult Volunteers With Breakthrough HIV Infection After Participation in a Preventive HIV Vaccine Trial
Baseline characteristics by cohort
| Measure |
Vaccine Group
n=49 Participants
Received vaccination in RV144
|
Placebo Group
n=65 Participants
Received placebo in RV144
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<20
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Age, Customized
21-25
|
18 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Age, Customized
>26
|
19 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Region of Enrollment
Thailand
|
49 participants
n=99 Participants
|
65 participants
n=107 Participants
|
114 participants
n=206 Participants
|
|
Calendar year of infection diagnosis
2004-2005
|
13 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Calendar year of infection diagnosis
2006
|
13 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Calendar year of infection diagnosis
2007
|
17 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Calendar year of infection diagnosis
2008-2009
|
6 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 66 monthsPopulation: Participants analyzed correlates to responders of endpoints
Evaluate the vaccine effect on clinical long term endpoints: CD4 is for CD4\<350 endpoint; ART is for initiation of highly-active antiretroviral therapy (HAART) endpoint; ADI is for AIDS-defining illness endpoint; A combination of multiple endpoints is listed in order of occurrences of the endpoints
Outcome measures
| Measure |
Vaccine Group
n=26 Participants
Received vaccination in RV144
|
Placebo Group
n=35 Participants
Received placebo in RV144
|
|---|---|---|
|
Number of Participants Reaching Clinical Long Term Component Endpoints
CD4 <350 only (CD4)
|
3 Participants
|
5 Participants
|
|
Number of Participants Reaching Clinical Long Term Component Endpoints
CD4-ART
|
18 Participants
|
23 Participants
|
|
Number of Participants Reaching Clinical Long Term Component Endpoints
CD4-ADI
|
0 Participants
|
0 Participants
|
|
Number of Participants Reaching Clinical Long Term Component Endpoints
CD4-ART-ADI
|
1 Participants
|
1 Participants
|
|
Number of Participants Reaching Clinical Long Term Component Endpoints
CD4-ADI-ART
|
1 Participants
|
2 Participants
|
|
Number of Participants Reaching Clinical Long Term Component Endpoints
ART Initiation only (ART)
|
1 Participants
|
3 Participants
|
|
Number of Participants Reaching Clinical Long Term Component Endpoints
ART-CD4
|
1 Participants
|
0 Participants
|
|
Number of Participants Reaching Clinical Long Term Component Endpoints
ART-ADI
|
0 Participants
|
0 Participants
|
|
Number of Participants Reaching Clinical Long Term Component Endpoints
ART-CD4-ADI
|
0 Participants
|
0 Participants
|
|
Number of Participants Reaching Clinical Long Term Component Endpoints
ART-ADI-CD4
|
0 Participants
|
0 Participants
|
|
Number of Participants Reaching Clinical Long Term Component Endpoints
AIDS Illness only (ADI)
|
0 Participants
|
0 Participants
|
|
Number of Participants Reaching Clinical Long Term Component Endpoints
ADI-CD4
|
0 Participants
|
0 Participants
|
|
Number of Participants Reaching Clinical Long Term Component Endpoints
ADI-ART
|
0 Participants
|
0 Participants
|
|
Number of Participants Reaching Clinical Long Term Component Endpoints
ADI-CD4-ART
|
1 Participants
|
1 Participants
|
|
Number of Participants Reaching Clinical Long Term Component Endpoints
ADI-ART-CD4
|
0 Participants
|
0 Participants
|
Adverse Events
Vaccine Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place