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HIV InfectionPhase 2GIEU006NCT00711230

Repeated DermaVir Immunizations in HIV-1 Infected Treatment-naïve Patients

A Phase 2 study testing DermaVir in people with HIV Infection, run by Genetic Immunity at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a single plasmid DNA expressing fifteen HIV antigens that assemble to HIV-like particles. These particles are safe; replication, integration and reverse transcription deficient. 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
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
3 sitesGermany
Study dates
Apr 2008to 1 Jan 2015
Phase
Phase 2
Are there results?
None posted in the registry

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

Main inclusion Criteria:

  • HIV antibody positive
  • Plasma HIV RNA value ≥5,000 copies/mL and ≤ 150,000 c/mL
  • Antiretroviral therapy naïve
  • Documented CD4+ T-cell count at screening ≥400 cells/mm3

Main exclusion Criteria:

  • No skin disease
  • No tattoos, or changes in pigmentation at the selected skin immunization sites
  • No acute or chronic illness (e.g Hepatitis C)
  • No chronic autoimmune diseases
  • No treatment with any immune modulating agents

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • ifi-Medizin GmbH at the Asklepios Klinik St. Georg

    Hamburg, 20099

  • ICH Grindel

    Hamburg, 20146

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20249

Other trials in Germany

About this study

Official title: A Phase II Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Safety, Tolerability, Immunogenicity, and Antiretroviral Activity of DermaVir Patch (LC002) in Treatment-Naïve HIV-1-Infected Patients

DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a single plasmid DNA expressing fifteen HIV antigens that assemble to HIV-like particles. These particles are safe; replication, integration and reverse transcription deficient. DermaVir is targeted to Langerhans cells by topical administration with DermaPrep. Langerhans cells with DermaVir migrate to lymph nodes and induce HIV-specific T cells that can kill HIV-infected cells.

GIEU006 is a Phase II randomized, placebo-controlled, dose-finding, double-blinded, multicenter study to assess the safety, tolerability, immunogenicity, and preliminary antiretroviral activity of DermaVir in antiretroviral therapy naïve adults with HIV-infection.

Read the detailed description

Patients were randomized into one of the following 6 arms:

  • Arm 1: Low dose DermaVir (0.2 mg DNA in 2 DermaPrep patches, n=9)
  • Arm 2: Low dose Placebo (2 DermaPrep patches, n=3)
  • Arm 3: Medium dose DermaVir (0.4 mg DNA in 4 DermaPrep patches, n=9)
  • Arm 4: Medium dose Placebo (4 DermaPrep patches, n=3)
  • Arm 5: High dose DermaVir (0.8 mg DNA in 8 DermaPrep patches, n=9)
  • Arm 6: High dose Placebo (8 DermaPrep patches, n=3) DermaPrep Patch size: 80 cm2. DermaVir Standard Unit per patch is 0.1 mg DNA = 0.8 mL of DermaVir nanomedicine.

The patch sites for immunization are preferably the left or right upper back and left or right upper ventral thigh. The same skin sites should be used for all immunizations.

Immunization schedule (Days): 0, 42, 84, and 126.

The total DermaVir dose:

  • Low dose: 0.8 mg DNA
  • Medium dose: 1.6 mg DNA
  • High Dose: 3.2 mg DNA

DermaVir immunizations were administered over an 18-week period Primary endpoint: 24 weeks Safety follow up: 234 weeks

Conditions
HIV Infection
Being tested
DermaVir, Placebo
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

  • PlaceboBiological

    glucose/dextrose

Study groups in NCT00711230
Study groupRoleWhat they receive
1: Low dose DermaVirExperimental* Dosage: 0.2 mg DNA * Dosage form: 1.6 mL DNA/PEIm nanomedicine * Administration with 2 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 DermaVir treatments)
Receives: Biological: DermaVir
2: Low dose PlaceboExperimental* Dosage form: 1.6 mL Placebo * Administration with 2 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 Placebo treatments)
Receives: Biological: Placebo
3: Medium dose DermaVirExperimental* Dosage: 0.4 mg DNA * Dosage form: 3.2 mL DNA/PEIm nanomedicine * Administration with 4 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 DermaVir treatments)
Receives: Biological: DermaVir
4: Medium dose PlaceboExperimental* Dosage form: 1.6 mL Placebo * Administration with 4 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 Placebo treatments)
Receives: Biological: Placebo
5: High dose DermaVirExperimental* Dosage: 0.8 mg DNA * Dosage form: 6.4 mL DNA/PEIm nanomedicine * Administration with 8 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 DermaVir treatments)
Receives: Biological: DermaVir
6: High dose PlaceboExperimental* Dosage form: 6.4 mL Placebo * Administration with 8 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 Placebo treatments)
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of participants with primary safety endpoint

    Primary safety endpoint: occurrence of at least two > Grade 3 adverse event including signs/symptoms, lab toxicities, and/or clinical events that is possibly or definitely related to study treatment (as judged by the GIEU006 team, including site clinicians on the team, blinded to treatment arm) any time from the first day of study treatment until 42 days after the last study vaccine administration.

    Measured: 24 weeks

Secondary outcomes (3)

  1. HIV-1 RNA

    Measured: 24 weeks

  2. CD4+ and CD8+ T-cell counts

    Measured: 24 weeks

  3. HIV-specific memory T cell responses

    Measured with Precursors with High Proliferative Capacity (PHPC) assay (Calarota et al. HIV-1-Specific T cell precursors with high proliferative capacity correlate with low viremia and high CD4 counts in untreated individuals. J Immunol 2008;180:5907-15)

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionDec 2011
  4. Study completion1 Jan 2015

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00711230
Sponsor's protocol ID
DermaVir Phase II
Other IDs
2007-001955-20
Acronym
GIEU006
Status last verified
Jan 2020
First submitted
4 Jul 2008
Last updated
28 Jan 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Lisziewicz 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 22590502

  • Lisziewicz 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

  • 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 21839051

  • Toke 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 20347027

  • Lori F. DermaVir: a plasmid DNA-based nanomedicine therapeutic vaccine for the treatment of HIV/AIDS. Expert Rev Vaccines. 2011 Oct;10(10):1371-84. doi: 10.1586/erv.11.118.

    PubMed 21988301

  • Somogyi 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 21109034

  • Calarota SA, Weiner DB, Lori F, Lisziewicz J. Induction of HIV-specific memory T-cell responses by topical DermaVir vaccine. Vaccine. 2007 Apr 20;25(16):3070-4. doi: 10.1016/j.vaccine.2007.01.024. Epub 2007 Jan 22.

    PubMed 17292518

  • Lisziewicz J, Trocio J, Whitman L, Varga G, Xu J, Bakare N, Erbacher P, Fox C, Woodward R, Markham P, Arya S, Behr JP, Lori F. DermaVir: a novel topical vaccine for HIV/AIDS. J Invest Dermatol. 2005 Jan;124(1):160-9. doi: 10.1111/j.0022-202X.2004.23535.x.

    PubMed 15654970

  • Lori F, Trocio J, Bakare N, Kelly LM, Lisziewicz J. DermaVir, a novel HIV immunisation technology. Vaccine. 2005 Mar 18;23(17-18):2030-4. doi: 10.1016/j.vaccine.2005.01.004.

    PubMed 15755566

  • Lisziewicz J, Trocio J, Xu J, Whitman L, Ryder A, Bakare N, Lewis MG, Wagner W, Pistorio A, Arya S, Lori F. Control of viral rebound through therapeutic immunization with DermaVir. AIDS. 2005 Jan 3;19(1):35-43. doi: 10.1097/00002030-200501030-00004.

    PubMed 15627031

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DermaVir in people with HIV Infection, run by Genetic Immunity at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percent of participants with primary safety endpoint (time frame: 24 weeks). 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 NCT00711230, which also lists 10 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 28 Jan 2020.

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