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Trial record 9 of 36 for:    " June 11, 2008":" July 11, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

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ClinicalTrials.gov Identifier: NCT00712530
Recruitment Status : Completed
First Posted : July 10, 2008
Results First Posted : March 26, 2013
Last Update Posted : March 26, 2013
Sponsor:
Information provided by (Responsible Party):
Genetic Immunity

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infection
Interventions Biological: DermaVir
Drug: HAART
Enrollment 9
Recruitment Details Nine subjects were sequentially enrolled into each cohort. Participants were recruited from the Szent László Hospital, Budapest, Hungary.
Pre-assignment Details 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.
Arm/Group Title 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
Hide Arm/Group Description

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 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 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)
Period Title: Overall Study
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
Arm/Group Title 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
Hide Arm/Group Description

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 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 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 of all reporting groups
Overall Number of Baseline Participants 3 3 3 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
3
 100.0%
3
 100.0%
9
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 3 participants 9 participants
45  (4.3) 34  (4.0) 36  (9.0) 38  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 9 participants
Female
1
  33.3%
1
  33.3%
0
   0.0%
2
  22.2%
Male
2
  66.7%
2
  66.7%
3
 100.0%
7
  77.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Hungary Number Analyzed 3 participants 3 participants 3 participants 9 participants
3 3 3 9
1.Primary Outcome
Title Grade 3 Adverse Event Related to DermaVir Treatment
Hide Description Occurrence of at least one grade 3 or higher adverse event including signs/symptoms, laboratory toxicities and clinical events possibly, probably or definitely related to study treatment as judged by the Principal Investigator or the site investigators during the 28 days after DermaVir administration.
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 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
Hide Arm/Group Description:

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 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 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)
Overall Number of Participants Analyzed 3 3 3
Measure Type: Number
Unit of Measure: participants
0 0 0
2.Secondary Outcome
Title CD4+ T Cell Counts/mm3
Hide Description [Not Specified]
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 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
Hide Arm/Group Description:

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 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 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)
Overall Number of Participants Analyzed 3 3 3
Mean (Standard Deviation)
Unit of Measure: CD4+ T cell counts/mm3
893  (461) 845  (68) 621  (185)
3.Secondary Outcome
Title Number of Subjects With Detectable Anti-ds Antibody and ANA
Hide Description [Not Specified]
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 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
Hide Arm/Group Description:

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 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 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)
Overall Number of Participants Analyzed 3 3 3
Measure Type: Number
Unit of Measure: participants
0 0 0
4.Secondary Outcome
Title Number of Subjects Having More Than 50 Copies/mL HIV RNA
Hide Description [Not Specified]
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 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
Hide Arm/Group Description:

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 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 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)
Overall Number of Participants Analyzed 3 3 3
Measure Type: Number
Unit of Measure: participants
0 0 0
5.Secondary Outcome
Title Change in HIV-specific Memory T Cell Responses at Day 28 Compare to Baseline
Hide Description HIV-specific T cell precursors with high proliferative capacity (PHPC) were quantified as described earlier [Calarota et al. J Immunol 2008]. Gag-, Tat- and Rev-specific T cells were measured representing ca. 25% of HIV epitopes included in DermaVir.
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 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
Hide Arm/Group Description:

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 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 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)
Overall Number of Participants Analyzed 3 3 3
Mean (Standard Deviation)
Unit of Measure: PHPC count
325  (266) 136202  (162287) 50759  (44792)
6.Other Pre-specified Outcome
Title Change in HIV-specific Memory T Cell Responses at Week 48
Hide Description

HIV-specific T cell precursors with high proliferative capacity (PHPC) were quantified as described earlier [Calarota et al. J Immunol 2008]. Gag-, Tat- and Rev-specific T cells were measured representing ca. 25% of HIV epitopes included in DermaVir.

Note, group Single low-dose was measured at 24 weeks, for this group the 48 weeks data is not available

Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 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
Hide Arm/Group Description:

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 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 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)
Overall Number of Participants Analyzed 3 3 3
Mean (Standard Deviation)
Unit of Measure: PHPC count
3899  (869) 9878  (10257) 18382  (21477)
Time Frame From start of study vaccination to study closure
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 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
Hide Arm/Group Description

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 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 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)
All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      1/3 (33.33%)      2/3 (66.67%)    
Blood and lymphatic system disorders       
HYPERBILIRUBINAEMY  [1]  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0
ELEVATED SE BILIRUBIN  [1]  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0
Gastrointestinal disorders       
NAUSEA  [2]  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1
General disorders       
FATIGUE  [2]  0/3 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0
Immune system disorders       
FEVER  [3]  2/3 (66.67%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0
CHILLS  [4]  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders       
LUMBALGY  [5]  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0
MYALGIAS  [6]  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders       
PRURITUS  [2]  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0
HYPERESTHESY ON THE SITES  [2]  0/3 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0
MACULAR ERYTHEMA  [7]  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1
Indicates events were collected by systematic assessment
[1]
Moderate
[2]
Mild
[3]
Mild, related to study medication
[4]
Mild, related to study medictaion
[5]
Mild, Not related to study medication
[6]
Mild,related to study medication
[7]
Mild, non related to study medication
This is a Phase I small sample study that was not powered for the secondary efficacy endpoints.
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.
Results Point of Contact
Name/Title: Dr. Denes Banhegyi
Organization: Szent Laszlo Hospital, Budapest, Hungary
Phone: +3614558152
Responsible Party: Genetic Immunity
ClinicalTrials.gov Identifier: NCT00712530     History of Changes
Other Study ID Numbers: GIHU004
First Submitted: July 4, 2008
First Posted: July 10, 2008
Results First Submitted: February 19, 2013
Results First Posted: March 26, 2013
Last Update Posted: March 26, 2013