Immunization With HIV-1 Peptides in Adjuvant for Treatment of Patients With Chronic HIV-infection (HIV-VAC)

This study has been completed.
Sponsor:
Collaborators:
Statens Serum Institut
Rigshospitalet, Denmark
Hvidovre University Hospital
Ministry of the Interior and Health, Denmark
Information provided by (Responsible Party):
Gitte Kronborg, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01009762
First received: November 6, 2009
Last updated: February 27, 2014
Last verified: February 2014
Results First Received: July 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: HIV INFECTIONS
Intervention: Biological: peptide vaccine (AFO-18)

  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
Participants were recruited at the infectious disease department at the University hospitals

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
20 participant numbers were randomised to vaccine or placebo but at the deadline for expiring of the vaccine only 11 participants were enrolled but all 11 completed the study

Reporting Groups
  Description
Saline Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
AFO-18 Vaccinated Patients receiving the experimental therapeutic vaccine

Participant Flow:   Overall Study
    Saline     AFO-18 Vaccinated  
STARTED     1     10  
Primary Outcome     0 [1]   0 [2]
COMPLETED     1 [3]   10 [4]
NOT COMPLETED     0     0  
[1] no Serious Adverse Events (SAE), no treatment related side effects DLT grade 3 or more
[2] no SAE, no treatment related side effects DLT grade 3 or more
[3] according to randomization this one participant received placebo
[4] 10 participants received vaccine



  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.
No text entered.

Reporting Groups
  Description
Saline Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
AFO-18 Vaccinated Patients receiving the experimental therapeutic vaccine
Total Total of all reporting groups

Baseline Measures
    Saline     AFO-18 Vaccinated     Total  
Number of Participants  
[units: participants]
  1     10     11  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     1     10     11  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     0     0     0  
Male     1     10     11  
Region of Enrollment  
[units: participants]
     
Denmark     1     10     11  
Clusters of Differentiation 4 (CD4) T-cells >400 cells/mm^3  
[units: participants]
  1     10     11  
Absence of T cell reaction to all vaccine peptides  
[units: participants]
  1     10     11  
Viral load >10^3/mm^3 plasma [1]
[units: participants]
  1     10     11  
[1] Numbers of participants with Viral Load in plasma above 1000 copies per ml



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Numbers of Treatment Related Side Effects (DLT = Reaction 3 or More)   [ Time Frame: up to 6 months after end of treatment ]

2.  Secondary:   Number of Participants With New T Cell Response to the Vaccine Target Epitopes   [ Time Frame: 10-14 days or 3 months or 6 months after last immunisation ]

3.  Secondary:   Numbers of Participants With Lowering of HIV RNA Viral-load   [ Time Frame: up to 6 months after treatment stop ]


  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
No text entered.


  More Information
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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: Professor Anders Fomsgaard
Organization: Statens Serum Institut
phone: +45-32683460
e-mail: afo@ssi.dk


Publications:
Publications automatically indexed to this study:

Responsible Party: Gitte Kronborg, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01009762     History of Changes
Other Study ID Numbers: EudraCT 2008-002980-15, 2008-002980-15
Study First Received: November 6, 2009
Results First Received: July 29, 2013
Last Updated: February 27, 2014
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee