Single DermaVir Immunization in HIV-1 Infected Patients on HAART (GIHU004)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genetic Immunity
ClinicalTrials.gov Identifier:
NCT00712530
First received: July 4, 2008
Last updated: February 19, 2013
Last verified: February 2013
Results First Received: February 19, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infection
Interventions: Biological: DermaVir
Drug: HAART

  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
Nine subjects were sequentially enrolled into each cohort. Participants were recruited from the Szent László Hospital, Budapest, Hungary.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The first three subjects received a single low-dose DermaVir immunization. Further enrolment of subjects into the medium and high dose cohorts began only after the safety data for cohorts low and medium doses, respectively were available, and the criteria for enrolling into the next cohort were met.

Reporting Groups
  Description
Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization

Single low-dose DermaVir immunization

  • 0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
  • Administered topically with DermaPrep under two skin patches (0.4 mL/patch)
Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization

Single medium-dose DermaVir immunization

  • 0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
  • Administered topically with DermaPrep under four skin patches (0.8 mL/patch)
Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization

Single high-dose DermaVir immunization

  • 0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
  • Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)

Participant Flow:   Overall Study
    Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization     Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization     Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization  
STARTED     3     3     3 [1]
COMPLETED     3     3     3  
NOT COMPLETED     0     0     0  
[1] Screened 4 patients, but one failed to meet entry criteria due to a history of bleeding and diabetes



  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
Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization

Single low-dose DermaVir immunization

  • 0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
  • Administered topically with DermaPrep under two skin patches (0.4 mL/patch)
Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization

Single medium-dose DermaVir immunization

  • 0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
  • Administered topically with DermaPrep under four skin patches (0.8 mL/patch)
Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization

Single high-dose DermaVir immunization

  • 0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
  • Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)
Total Total of all reporting groups

Baseline Measures
    Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization     Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization     Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization     Total  
Number of Participants  
[units: participants]
  3     3     3     9  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     3     3     3     9  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  45  ± 4.3     34  ± 4.0     36  ± 9.0     38  ± 7.4  
Gender  
[units: participants]
       
Female     1     1     0     2  
Male     2     2     3     7  
Region of Enrollment  
[units: participants]
       
Hungary     3     3     3     9  



  Outcome Measures
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1.  Primary:   Grade 3 Adverse Event Related to DermaVir Treatment   [ Time Frame: 28 days ]

2.  Secondary:   CD4+ T Cell Counts/mm3   [ Time Frame: 28 days ]

3.  Secondary:   Number of Subjects With Detectable Anti-ds Antibody and ANA   [ Time Frame: 28 days ]

4.  Secondary:   Number of Subjects Having More Than 50 Copies/mL HIV RNA   [ Time Frame: 28 days ]

5.  Secondary:   Change in HIV-specific Memory T Cell Responses at Day 28 Compare to Baseline   [ Time Frame: 28 days ]

6.  Other Pre-specified:   Change in HIV-specific Memory T Cell Responses at Week 48   [ Time Frame: 48 weeks ]


  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
This is a Phase I small sample study that was not powered for the secondary efficacy endpoints.


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Denes Banhegyi
Organization: Szent Laszlo Hospital, Budapest, Hungary
phone: +3614558152
e-mail: immunol@mail.datanet.hu


Publications of Results:
Other Publications:

Responsible Party: Genetic Immunity
ClinicalTrials.gov Identifier: NCT00712530     History of Changes
Other Study ID Numbers: GIHU004
Study First Received: July 4, 2008
Results First Received: February 19, 2013
Last Updated: February 19, 2013
Health Authority: Hungary: National Institute of Pharmacy