HIV InfectionPhase 1GIHU004NCT00712530
Single DermaVir Immunization in HIV-1 Infected Patients on HAART
A Phase 1 study testing DermaVir and HAART in people with HIV Infection, run by Genetic Immunity at 1 site in Hungary.
Trial summary
DermaVir is a plasmid DNA-containing synthetic nanomedicine. It is administered topically with DermaPrep to target Langerhans cells. Langerhans cells with DermaVir migrate to lymph nodes and express HIV-like particles that induce immune responses to kill HIV-infected cells. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- DermaVir and HAART
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteHungary
- Study dates
- Jan 2005to Jun 2006
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ability and willingness of subject or legal guardian/representative to give written informed consent
- HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA
- On a stable antiretroviral regimen without changes or interruptions for at least 12 weeks prior to study entry
- Plasma HIV-1 RNA level of less than 50 copies/mL, obtained at least twice within the 12 weeks prior to study entry
- Peak plasma HIV-1 RNA level before initiation of HAART > 1000 copies/mL
- CD4 cell count > 300 cells/mm3 within the 12 weeks prior to study entry
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- Nadir (lowest) CD4+ cell count > 250 cells/mm3 at any time prior to study entry
- The following laboratory values, obtained within 30 days prior to study entry:
- Absolute neutrophil count (ANC) > 1000/mm3
- Hemoglobin > 9.0 g/dL
- Platelet count > 50,000/mm3
- Serum creatinine < upper limit of the laboratory normal range (ULN)
- AST (SGOT), ALT (SGPT), and alkaline phosphatase < 2.5 x ULN
- Total bilirubin < 2.5 x ULN
- Anti-nuclear antibody (ANA) titer of 1:40 or lower and negative for serum anti-double-stranded DNA antibody (anti-ds-DNA) test result at screening.
- All women of reproductive potential must have a negative urine beta-HCG pregnancy test performed within 14 days prior to study entry.
- Female study volunteers who are not of reproductive potential or whose male partner has undergone successful vasectomy are eligible without requiring the use of contraception. Acceptable documentation of menopause, sterilization, and azoospermia is written or oral documentation communicated by clinician.
- All subjects must not participate in a conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) and, if participating in sexual activity that could lead to pregnancy, the study volunteer/ partner must use two reliable methods of contraception simultaneously while receiving the protocol-specified vaccination and for 3 months after the last vaccination.
- Karnofsky performance score > 90 within 30 days prior to study entry
- Men and women age 18-50 years
Who cannot join
- Viral load measurement > 50 copies/mL within the last 12 weeks prior to study entry
- History of or evidence of active skin disease (e.g. atopic dermatitis), chronic autoimmune disease or any other significant active skin disease
- Treatment with topical corticosteroids in close proximity to the proposed vaccination sites within 2 weeks prior to study entry
- Excessive exposure to the sun (e.g. sunbathing) within 2 weeks prior to study entry
- Use of any local skin treatments to the targeted vaccination sites within 7 days prior to study entry
- History of diabetes and bleeding disorders
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- Previous CDC category C event
- Pregnancy or breast-feeding
- Use of immunomodulating therapy, including cyclosporin, IgG-containing products, interleukins, interferons, systemic glucocorticosteroids, or exposure to an experimental HIV vaccine within 6 months prior to study entry
- Receipt of any vaccine within 30 days prior to study entry
- Allergy/sensitivity to study vaccine products, including adhesives, will be excluded
- Active drug or alcohol use or dependence
- Serious illness until subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 14 days prior to study entry
- Hepatitis B surface antigen and/or anti-hepatitis C positive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate the Tolerability and Safety of LC002, a DermaVir Vaccine, in HIV-1-infected Subjects Currently Under Treatment With Highly Active Antiretroviral Therapy (HAART)
- DermaVir is a plasmid DNA-containing synthetic nanomedicine. It is administered topically with DermaPrep to target Langerhans cells. Langerhans cells with DermaVir migrate to lymph nodes and express HIV-like particles that induce immune responses to kill HIV-infected cells.
- Hypothesis: Single DermaVir immunization is safe and immunogenic measured by induction of HIV-specific precursor/memory T cell responses.
- GIHU004 was a phase I dose escalation study conducted in Hungary. It evaluated the safety and immunogenicity of three dosing regimens of topical DermaVir immunization for the treatment of HIV-infected individuals on fully suppressive highly active antiretroviral therapy (HAART).
Read the detailed description
This study enrolled nine HIV-infected adult subjects in three sequential dose cohorts. All had durable suppression of HIV-RNA on HAART over the previous 6 months and CD4 count over 300 cells/mm3. Subjects, received on study Day 0 a single DermaVir immunization:
- Low dose: 0.1 mg pDNA, 0.8 mL DermaVir administered under two DermaPrep patches.
- Medium dose: 0.4 mg pDNA, 3.2 mL DermaVir administered under four DermaPrep patches.
- High dose: 0.8 mg pDNA, 6.4 mL DermaVir administered under eight DermaPrep patches.
Subjects were on study for a total of 28 days followed by a post-treatment safety follow-up for 48 weeks. HAART was not interrupted. All subjects completed the 28-day treatment and 48 weeks safety follow up phase.
- Conditions
- HIV Infection
- Being tested
- DermaVir, HAART
- Keywords
- HIV, Vaccine, Immune Therapy, DermaVir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermaVirBiological
Also called LC002
DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a plasmid DNA expressing fifteen HIV proteins that assemble into HIV-like particles. These particles are safe, cannot replicate, integrate or reverse transcribed. DermaVir is targeted to Langerhans cells with DermaPrep medical device. These DermaVir-containing Langerhans cells migrate to the lymph nodes, where induce HIV-specific cytotoxic T cells that can recognize and kill HIV-infected cells.
HAARTDrug
Also called Highly active antiretroviral therapy
Three or more antiretroviral drugs that can fully suppress HIV RNA
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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) Receives: Biological: DermaVir; Drug: HAART |
| 2 | Experimental | 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) Receives: Biological: DermaVir; Drug: HAART |
| 3 | Experimental | 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) Receives: Biological: DermaVir; Drug: HAART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 3 Adverse Event Related to DermaVir Treatment
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.
Measured: 28 days
Secondary outcomes (4)
CD4+ T Cell Counts/mm3
Measured: 28 days
Number of Subjects With Detectable Anti-ds Antibody and ANA
Measured: 28 days
Number of Subjects Having More Than 50 Copies/mL HIV RNA
Measured: 28 days
Change in HIV-specific Memory T Cell Responses at Day 28 Compare to Baseline
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startJan 2005
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genetic Immunity
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Denes Banhegyi, MD, Principal investigator, Saint Laszlo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712530
- Sponsor's protocol ID
- GIHU004
- Acronym
- GIHU004
- Status last verified
- Feb 2013
- First submitted
- 4 Jul 2008
- Last updated
- 26 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lorincz O, Toke ER, Somogyi E, Horkay F, Chandran PL, Douglas JF, Szebeni J, Lisziewicz J. Structure and biological activity of pathogen-like synthetic nanomedicines. Nanomedicine. 2012 May;8(4):497-506. doi: 10.1016/j.nano.2011.07.013. Epub 2011 Aug 10.
PubMed 21839051Somogyi E, Xu J, Gudics A, Toth J, Kovacs AL, Lori F, Lisziewicz J. A plasmid DNA immunogen expressing fifteen protein antigens and complex virus-like particles (VLP+) mimicking naturally occurring HIV. Vaccine. 2011 Jan 17;29(4):744-53. doi: 10.1016/j.vaccine.2010.11.019. Epub 2010 Nov 23.
PubMed 21109034Toke ER, Lorincz O, Somogyi E, Lisziewicz J. Rational development of a stable liquid formulation for nanomedicine products. Int J Pharm. 2010 Jun 15;392(1-2):261-7. doi: 10.1016/j.ijpharm.2010.03.048. Epub 2010 Mar 25.
PubMed 20347027Calarota SA, Foli A, Maserati R, Baldanti F, Paolucci S, Young MA, Tsoukas CM, Lisziewicz J, Lori F. HIV-1-specific T cell precursors with high proliferative capacity correlate with low viremia and high CD4 counts in untreated individuals. J Immunol. 2008 May 1;180(9):5907-15. doi: 10.4049/jimmunol.180.9.5907.
PubMed 18424710Lisziewicz J, Bakare N, Calarota SA, Banhegyi D, Szlavik J, Ujhelyi E, Toke ER, Molnar L, Lisziewicz Z, Autran B, Lori F. Single DermaVir immunization: dose-dependent expansion of precursor/memory T cells against all HIV antigens in HIV-1 infected individuals. PLoS One. 2012;7(5):e35416. doi: 10.1371/journal.pone.0035416. Epub 2012 May 9.
PubMed 22590502Lisziewicz J, Toke ER. Nanomedicine applications towards the cure of HIV. Nanomedicine. 2013 Jan;9(1):28-38. doi: 10.1016/j.nano.2012.05.012. Epub 2012 May 30.
PubMed 22659241
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Tolerability and Safety of LC002, a DermaVir Vaccine, in HIV-1-infected Subjects Currently Under Treatment With Highly Active Antiretroviral Therapy (HAART)
- ClinicalTrials.gov ID
- NCT00712530
- Acronym / sponsor ID
- GIHU004 / GIHU004
- Conditions
- HIV Infection
- Keywords
- HIV, Vaccine, Immune Therapy, DermaVir
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Genetic ImmunityIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 10 Jul 2008 (estimated)
- Results
- Posted 26 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- DermaVir is a plasmid DNA-containing synthetic nanomedicine. It is administered topically with DermaPrep to target Langerhans cells. Langerhans cells with DermaVir migrate to lymph nodes and express HIV-like particles that induce immune responses to kill HIV-infected cells.
- Hypothesis: Single DermaVir immunization is safe and immunogenic measured by induction of HIV-specific precursor/memory T cell responses.
- GIHU004 was a phase I dose escalation study conducted in Hungary. It evaluated the safety and immunogenicity of three dosing regimens of topical DermaVir immunization for the treatment of HIV-infected individuals on fully suppressive highly active antiretroviral therapy (HAART).
Detailed description
This study enrolled nine HIV-infected adult subjects in three sequential dose cohorts. All had durable suppression of HIV-RNA on HAART over the previous 6 months and CD4 count over 300 cells/mm3. Subjects, received on study Day 0 a single DermaVir immunization:
- Low dose: 0.1 mg pDNA, 0.8 mL DermaVir administered under two DermaPrep patches.
- Medium dose: 0.4 mg pDNA, 3.2 mL DermaVir administered under four DermaPrep patches.
- High dose: 0.8 mg pDNA, 6.4 mL DermaVir administered under eight DermaPrep patches.
Subjects were on study for a total of 28 days followed by a post-treatment safety follow-up for 48 weeks. HAART was not interrupted. All subjects completed the 28-day treatment and 48 weeks safety follow up phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: DermaVir, Drug: HAARTSingle 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) |
| 2 | Experimental | Biological: DermaVir, Drug: HAARTSingle 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) |
| 3 | Experimental | Biological: DermaVir, Drug: HAARTSingle 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) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Ability and willingness of subject or legal guardian/representative to give written informed consent
- HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA
- On a stable antiretroviral regimen without changes or interruptions for at least 12 weeks prior to study entry
- Plasma HIV-1 RNA level of less than 50 copies/mL, obtained at least twice within the 12 weeks prior to study entry
- Peak plasma HIV-1 RNA level before initiation of HAART > 1000 copies/mL
Key exclusion criteria (14 listed)
- Viral load measurement > 50 copies/mL within the last 12 weeks prior to study entry
- History of or evidence of active skin disease (e.g. atopic dermatitis), chronic autoimmune disease or any other significant active skin disease
- Treatment with topical corticosteroids in close proximity to the proposed vaccination sites within 2 weeks prior to study entry
- Excessive exposure to the sun (e.g. sunbathing) within 2 weeks prior to study entry
- Use of any local skin treatments to the targeted vaccination sites within 7 days prior to study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DermaVirAlso: LC002DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a plasmid DNA expressing fifteen HIV proteins that assemble into HIV-like particles. These particles are safe, cannot replicate, integrate or reverse transcribed. DermaVir is targeted to Langerhans cells with DermaPrep medical device. These DermaVir-containing Langerhans cells migrate to the lymph nodes, where induce HIV-specific cytotoxic T cells that can recognize and kill HIV-infected cells. | Biological | 1, 2, 3 |
| HAARTAlso: Highly active antiretroviral therapyThree or more antiretroviral drugs that can fully suppress HIV RNA | Drug | 1, 2, 3 |
Primary outcome
Grade 3 Adverse Event Related to DermaVir Treatment
Time frame: 28 days
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.
4 secondary outcomes
CD4+ T Cell Counts/mm3
Time frame: 28 days
Number of Subjects With Detectable Anti-ds Antibody and ANA
Time frame: 28 days
Number of Subjects Having More Than 50 Copies/mL HIV RNA
Time frame: 28 days
Change in HIV-specific Memory T Cell Responses at Day 28 Compare to Baseline
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21839051Lorincz O, Toke ER, Somogyi E, Horkay F, Chandran PL, Douglas JF, Szebeni J, Lisziewicz J. Structure and biological activity of pathogen-like synthetic nanomedicines. Nanomedicine. 2012 May;8(4):497-506. doi: 10.1016/j.nano.2011.07.013. Epub 2011 Aug 10.
- Background: PubMed 21109034Somogyi E, Xu J, Gudics A, Toth J, Kovacs AL, Lori F, Lisziewicz J. A plasmid DNA immunogen expressing fifteen protein antigens and complex virus-like particles (VLP+) mimicking naturally occurring HIV. Vaccine. 2011 Jan 17;29(4):744-53. doi: 10.1016/j.vaccine.2010.11.019. Epub 2010 Nov 23.
- Background: PubMed 20347027Toke ER, Lorincz O, Somogyi E, Lisziewicz J. Rational development of a stable liquid formulation for nanomedicine products. Int J Pharm. 2010 Jun 15;392(1-2):261-7. doi: 10.1016/j.ijpharm.2010.03.048. Epub 2010 Mar 25.
- Background: PubMed 18424710Calarota SA, Foli A, Maserati R, Baldanti F, Paolucci S, Young MA, Tsoukas CM, Lisziewicz J, Lori F. HIV-1-specific T cell precursors with high proliferative capacity correlate with low viremia and high CD4 counts in untreated individuals. J Immunol. 2008 May 1;180(9):5907-15. doi: 10.4049/jimmunol.180.9.5907.
- Results publication: PubMed 22590502Lisziewicz J, Bakare N, Calarota SA, Banhegyi D, Szlavik J, Ujhelyi E, Toke ER, Molnar L, Lisziewicz Z, Autran B, Lori F. Single DermaVir immunization: dose-dependent expansion of precursor/memory T cells against all HIV antigens in HIV-1 infected individuals. PLoS One. 2012;7(5):e35416. doi: 10.1371/journal.pone.0035416. Epub 2012 May 9.
- Results publication: PubMed 22659241Lisziewicz J, Toke ER. Nanomedicine applications towards the cure of HIV. Nanomedicine. 2013 Jan;9(1):28-38. doi: 10.1016/j.nano.2012.05.012. Epub 2012 May 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denes Banhegyi, MD principal investigator
Saint Laszlo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DermaVir and HAART in people with HIV Infection, run by Genetic Immunity at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 3 Adverse Event Related to DermaVir Treatment (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00712530, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2013.