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Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bionor Immuno AS
ClinicalTrials.gov Identifier:
NCT00659789
First received: April 14, 2008
Last updated: January 5, 2017
Last verified: November 2016
Results First Received: July 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: HIV I Infection
Interventions: Drug: Vacc-4x
Drug: Sterile water

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first subject was screened on 29 July 2008 and the first immunization was given on 22 August 2008. The last subject completed the study (to Week 52) on 22 June 2010. The last long-term follow-up visit was 07 June 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
137 study participants were enrolled. One participant withdrew prior to randomization.

Reporting Groups
  Description
Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
Placebo Injections (Group II) While on ART Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.

Participant Flow:   Overall Study
    Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART   Placebo Injections (Group II) While on ART
STARTED   93   43 
COMPLETED   86   36 
NOT COMPLETED   7   7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population

Reporting Groups
  Description
Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
Placebo Injections (Group II) While on ART Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
Total Total of all reporting groups

Baseline Measures
   Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART   Placebo Injections (Group II) While on ART   Total 
Overall Participants Analyzed 
[Units: Participants]
 92   43   135 
Age, Customized 
[Units: Participants]
Count of Participants
     
Age, Categorial       
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 15 and 55      92 100.0%      43 100.0%      135 100.0% 
>=55 years      0   0.0%      0   0.0%      0   0.0% 
Gender 
[Units: Participants]
Count of Participants
     
Female      14  15.2%      5  11.6%      19  14.1% 
Male      78  84.8%      38  88.4%      116  85.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1   2.3%      1   0.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4   4.3%      5  11.6%      9   6.7% 
White      88  95.7%      37  86.0%      125  92.6% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Height 
[Units: Cm]
Median (Full Range)
 175 
 (155 to 190) 
 175 
 (159 to 200) 
 175 
 (155 to 200) 
Time since HIV diagnosis (days) 
[Units: Days]
Median (Full Range)
 3861 
 (466 to 8794) 
 4480 
 (814 to 8990) 
 4309 
 (466 to 8990) 
CD4 nadir 
[Units: 10^6 cells/L]
Median (Full Range)
 300 
 (200 to 734) 
 285 
 (200 to 724) 
 298 
 (200 to 734) 
Pre-ART CD4 
[Units: 10^6 cells/L]
Median (Full Range)
 339 
 (177 to 1396) 
 370 
 (207 to 924) 
 357 
 (177 to 1396) 
Pre-ART HIV-1 viral load 
[Units: copies/mL]
Median (Full Range)
 94810 
 (120 to 2500000) 
 25630 
 (412 to 1460000) 
 75398 
 (120 to 2500000) 
Total time on ART 
[Units: Months]
Median (Full Range)
 95.5 
 (13 to 276) 
 112 
 (13 to 197) 
 108 
 (13 to 276) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52.   [ Time Frame: From Week 28 to Week 52 ]

2.  Secondary:   Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths   [ Time Frame: Up to week 52 ]

3.  Secondary:   Immunogenicity   [ Time Frame: Week 1, week 18 and week 52 ]

4.  Secondary:   Effect of Vacc-4x on CD8 Counts   [ Time Frame: Weeks 6,18,24,28,32,36,40,44,48,52. ]

5.  Secondary:   Time to Restart of ART for Vacc-4x Subjects Versus Placebo   [ Time Frame: Between Week 28 to Week 52 ]

6.  Secondary:   Effects on Vacc-4x on HIV-1 RNA   [ Time Frame: Weeks 24,28,32,36,40,44,48,52. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Maja Sommerfelt
Organization: Bionor Pharma ASA
phone: +4723010960
e-mail: ms@bionorpharma.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bionor Immuno AS
ClinicalTrials.gov Identifier: NCT00659789     History of Changes
Other Study ID Numbers: CT-BI Vacc-4x 2007/1
2007-006302-13 ( EudraCT Number )
13619 ( Other Identifier: FDA IND )
Study First Received: April 14, 2008
Results First Received: July 22, 2015
Last Updated: January 5, 2017