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HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease (HIV-BIS)

This study has been completed.
Sponsor:
Collaborators:
Ministry of the Interior and Health, Denmark
European and Developing Countries Clinical Trials Partnership (EDCTP)
Information provided by (Responsible Party):
Anders Fomsgaard, Statens Serum Institut
ClinicalTrials.gov Identifier:
NCT01141205
First received: June 9, 2010
Last updated: August 2, 2013
Last verified: August 2013
History of Changes
Results First Received: June 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Participant);   Primary Purpose: Treatment
Condition: Aids, Cdc Group I
Interventions: Biological: AFO-18
Drug: Saline

  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
medical clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
AFO-18 18 peptides representing 15 CD8 and 3 CD4 epitopes on HIV-1 plus 1 CD4 T helper epitope unrelated to HIV in an adjuvant (CAF01). Total 4.5 mg peptide (250 micro gram of each peptide) in CAF01 adjuvant. Total volume of 1.25 ml was injected i.m. (in m. deltoideus) at weeks 0, 2, 4, 8
Saline Placebo was Sterile saline injection, 1.25 ml i.m. (in m. deltoideus) at each vaccination weeks 0, 2, 4, 8

Participant Flow:   Overall Study
    AFO-18   Saline
STARTED   18   5 
COMPLETED   15   3 
NOT COMPLETED   3   2 
Physician Decision                1                1 
Lost to Follow-up                1                0 
Withdrawal by Subject                1                1 



  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
AFO-18 18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
Saline Saline injection
Total Total of all reporting groups

Baseline Measures
   AFO-18   Saline   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 18   5   23 
Age 
[Units: Participants]
 		     
<=18 years   0   0   0 
Between 18 and 65 years   18   5   23 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation) 		 34  (2)   29  (2)   32  (2) 
Gender 
[Units: Participants]
 		     
Female   17   3   20 
Male   1   2   3 
Region of Enrollment 
[Units: Participants]
 		     
Guinea-Bissau   18   5   23 


  Outcome Measures
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1.  Primary:   Tolerability and Safety of the Treatment.   [ Time Frame: up to 6 months after end of treatment ]
  Show Outcome Measure 1

2.  Secondary:   Induction of New T-cell Immune Response by the Vaccine   [ Time Frame: up to 6 months after last immunisation ]
  Show Outcome Measure 2

3.  Secondary:   Lowering of HIV-1 RNA Viral-load in HIV-1 Immune Responders More Than 1 Log   [ Time Frame: up to 6 months post immunization ]
  Show Outcome Measure 3

4.  Secondary:   Increase in Blood CD4 T-cell Counts   [ Time Frame: up to 6 months post vaccination ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Anders Fomsgaard
Organization: Statens Serum Institut
phone: +45-32683460
e-mail: afo@ssi.dk


Publications of Results:


Responsible Party: Anders Fomsgaard, Statens Serum Institut
ClinicalTrials.gov Identifier: NCT01141205     History of Changes
Other Study ID Numbers: HIV-BIS NCP03/2009
EDCTP_MSI.2009.10800.001 ( Other Grant/Funding Number: EDCTP_MSI.2009.10800.001 )
Study First Received: June 9, 2010
Results First Received: June 13, 2012
Last Updated: August 2, 2013