Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Follow up of Thai Adult Volunteers With Breakthrough HIV Infection After Participation in a Preventive HIV Vaccine Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00337181
Recruitment Status : Completed
First Posted : June 15, 2006
Results First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Collaborators:
Walter Reed Army Institute of Research (WRAIR)
Royal Thai Ministry of Public Health
Mahidol University
Armed Forces Research Institute of Medical Sciences, Thailand
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition HIV-1
Enrollment 114
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vaccine Group Placebo Group
Hide Arm/Group Description Received vaccination in RV144 Received placebo in RV144
Period Title: Overall Study
Started 49 65
Completed 49 65
Not Completed 0 0
Arm/Group Title Vaccine Group Placebo Group Total
Hide Arm/Group Description Received vaccination in RV144 Received placebo in RV144 Total of all reporting groups
Overall Number of Baseline Participants 49 65 114
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 65 participants 114 participants
<20
12
  24.5%
10
  15.4%
22
  19.3%
21-25
18
  36.7%
33
  50.8%
51
  44.7%
>26
19
  38.8%
22
  33.8%
41
  36.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 65 participants 114 participants
Female
19
  38.8%
28
  43.1%
47
  41.2%
Male
30
  61.2%
37
  56.9%
67
  58.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Thailand Number Analyzed 49 participants 65 participants 114 participants
49 65 114
Calendar year of infection diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 65 participants 114 participants
2004-2005
13
  26.5%
17
  26.2%
30
  26.3%
2006
13
  26.5%
26
  40.0%
39
  34.2%
2007
17
  34.7%
10
  15.4%
27
  23.7%
2008-2009
6
  12.2%
12
  18.5%
18
  15.8%
1.Primary Outcome
Title Number of Participants Reaching Clinical Long Term Component Endpoints
Hide Description 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
Time Frame 66 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed correlates to responders of endpoints
Arm/Group Title Vaccine Group Placebo Group
Hide Arm/Group Description:
Received vaccination in RV144
Received placebo in RV144
Overall Number of Participants Analyzed 26 35
Measure Type: Count of Participants
Unit of Measure: Participants
CD4 <350 only (CD4)
3
  11.5%
5
  14.3%
CD4-ART
18
  69.2%
23
  65.7%
CD4-ADI
0
   0.0%
0
   0.0%
CD4-ART-ADI
1
   3.8%
1
   2.9%
CD4-ADI-ART
1
   3.8%
2
   5.7%
ART Initiation only (ART)
1
   3.8%
3
   8.6%
ART-CD4
1
   3.8%
0
   0.0%
ART-ADI
0
   0.0%
0
   0.0%
ART-CD4-ADI
0
   0.0%
0
   0.0%
ART-ADI-CD4
0
   0.0%
0
   0.0%
AIDS Illness only (ADI)
0
   0.0%
0
   0.0%
ADI-CD4
0
   0.0%
0
   0.0%
ADI-ART
0
   0.0%
0
   0.0%
ADI-CD4-ART
1
   3.8%
1
   2.9%
ADI-ART-CD4
0
   0.0%
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description A final report can't be located for this protocol. Results info was pulled from an abstract published after study completion. AEs were not referenced in the abstract so therefore there are no AEs to report.
 
Arm/Group Title Vaccine Group Placebo Group
Hide Arm/Group Description Received vaccination in RV144 Received placebo in RV144
All-Cause Mortality
Vaccine Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Vaccine Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vaccine Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
A final report can't be located for this protocol. Results were pulled from an abstract that was published after completion. Outcome endpoints in protocol description will not match final outcome measures in results section. AE's can't be located.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Supachai Rerks-Ngarm
Organization: Thai Ministry of Public Health
Phone: 6629659571
Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00337181     History of Changes
Other Study ID Numbers: A-11048
RV152 ( Other Identifier: WRAIR )
First Submitted: June 14, 2006
First Posted: June 15, 2006
Results First Submitted: December 6, 2017
Results First Posted: August 22, 2018
Last Update Posted: August 22, 2018