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HIV InfectionPHPC-02NCT00918840

Antiretroviral-Sparing Concept With HIV-specific T Cell Precursors With High Proliferative Capacity (PHPC)

An observational study of HIV Infection, run by Genetic Immunity at 1 site in Italy.

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

PHPC-02 is a phase II, randomized, placebo-controlled trial designed to investigate whether therapeutic immunization during highly active antiretroviral therapy (HAART) induces elevations of HIV-specific T cell precursors with high proliferative capacity (PHPC) in HIV-1-infected individuals, and whether the quantity… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
HIV Infection
What is being tested?
DermaVir and HAART
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteItaly
Study dates
Apr 2009to Jun 2011
Phase
Observational
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 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Primary care clinic

Main inclusion Criteria:

  • HIV-1 infection
  • On a non-hydroxyurea based HAART for at least one year
  • Pre-HAART CD4 nadir > 250 cells/mm3
  • Pre-HAART viral load > 5,000 copies/mL
  • Undetectable viral load for the six month period preceding the study
  • CD4 T-cell count >500 cells/mm3 for the six month period preceding the study

Main exclusion Criteria:

  • No skin disease
  • No hypersensitivity to adhesive tape or Tegaderm
  • No history of keloid
  • No history of vitiligo, melasma, skin cancer
  • No tattoos or changes in pigment at the skin treatment sites
  • No autoimmune diseases
  • No hepatitis B, C coinfections

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • IRCCS Policlinico S. Matteo

    Pavia, 27100

Other trials in Italy

About this study

Official title: Antiretroviral-Sparing Concept: An Exploratory Phase II, Randomized, Single Blind Placebo-Controlled Study to Investigate the Effect of Therapeutic Immunization on the Quantity of HIV-Specific T Cell Precursors During Highly Active Antiretroviral Therapy Followed by Analytical Treatment Interruption

PHPC-02 is a phase II, randomized, placebo-controlled trial designed to investigate whether therapeutic immunization during highly active antiretroviral therapy (HAART) induces elevations of HIV-specific T cell precursors with high proliferative capacity (PHPC) in HIV-1-infected individuals, and whether the quantity of PHPC correlates with the viral load set point following analytical treatment interruption (ATI). Subjects will be randomized to receive either DermaVir Patch (8 subjects per cohort) or DermaVir Patch Placebo (8 subjects per cohort) every four weeks for three applications while receiving maximally suppressive HAART. HAART will be discontinued at Week 9 for an ATI period of 20 weeks.

Read the detailed description

16 subjects on maximally suppressive HAART were randomized to receive three doses of either DermaVir or Placebo immunotherapy.

Subjects receive three DermaVir/Placebo treatments over eight weeks (Weeks 0, 4 and 8) while receiving HAART. HAART is discontinued for a 20 week ATI.

Resumption of HAART during ATI is subjects experience:

  • A confirmed CD4+ cell decrease by > 50%
  • A confirmed CD4+ cell decrease to less than 350 counts/mL
  • A confirmed VL increase > 300,000 copies
  • Emergence of CDC AIDS related event(s)
  • Signs or symptoms of clinically significant immunosuppression
  • The subject or the subject's clinician wishes to restart HAART
  • The subject becomes pregnant
Conditions
HIV Infection
Being tested
DermaVir, Placebo, HAART
Keywords
HIV, Vaccine, Immune Therapy, DermaVir, Treatment experienced
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 nanomedicine. The active pharmaceutical ingredient is a single plasmid DNA expressing 15 HIV proteins that assemble to HIV-like particles. DermaVir is topically administered with DermaPrep medical device to target the nanomedicine to Langerhans cells of the skin.These Langerhans cells migrate to the lymph node to induce cytotoxic T cells that can kill HIV-infected cells

  • PlaceboBiological

    Also called LC002 Placebo

    Dextrose/glucose solution

  • HAARTDrug

    Also called Highly active antiretroviral therapy

    Three or more antiretroviral drugs that can fully suppress HIV RNA

Study groups in NCT00918840
Study groupRoleWhat they receive
DermaVir + HAART* Dosage: 0.4 mg DNA * Dosage form: 3.2 mL DNA/PEIm nanomedicine * Administration with 4 DermaPrep patches * Frequency: every 4 weeks * Duration: 8 weeks (3 DermaVir treatments)
Receives: Biological: DermaVir; Drug: HAART
Placebo + HAART* Dosage form: 3.2 mL Placebo * Administration with 4 DermaPrep patches * Frequency: every four weeks * Duration: 8 weeks (3 Placebo treatments)
Receives: Biological: Placebo; Drug: HAART

What is being measured

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

  1. HIV-specific memory T cells measured as PHPC count

    DermaVir-induced PHPC count compared to Placebo

    Measured: 9 week

Secondary outcomes (3)

  1. HIV-1 RNA

    HIV-1 RNA set-point after analytical treatment interruption

    Measured: weeks 16 and 20

  2. CD4+ and CD8+ T cell counts

    Measured: 20 weeks

  3. Adverse Events

    Measured: 20 weeks

Timeline

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

  1. First posted11 Jun 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00918840
Sponsor's protocol ID
PHPC-02
Other IDs
2008-003765-11, 2008
Acronym
PHPC-02
Status last verified
Feb 2013
First submitted
8 Jun 2009
Last updated
8 Feb 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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

  • 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

  • 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

  • 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, 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 18424710

  • Cristillo AD, Lisziewicz J, He L, Lori F, Galmin L, Trocio JN, Unangst T, Whitman L, Hudacik L, Bakare N, Whitney S, Restrepo S, Suschak J, Ferrari MG, Chung HK, Kalyanaraman VS, Markham P, Pal R. HIV-1 prophylactic vaccine comprised of topical DermaVir prime and protein boost elicits cellular immune responses and controls pathogenic R5 SHIV162P3. Virology. 2007 Sep 15;366(1):197-211. doi: 10.1016/j.virol.2007.04.012. Epub 2007 May 11.

    PubMed 17499328

  • 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

  • Lori F, Foli A, Lisziewicz J. Stopping HAART temporarily in the absence of virus rebound: exploring new HIV treatment options. Curr Opin HIV AIDS. 2007 Jan;2(1):14-20. doi: 10.1097/COH.0b013e328011aad6.

    PubMed 19372860

  • Xu JQ, Lori F, Lisziewicz J. CD4+ T cell-mediated presentation of non-infectious HIV-1 virion antigens to HIV-specific CD8+ T cells. Chin Med J (Engl). 2006 Oct 5;119(19):1629-38.

    PubMed 17042976

  • 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

  • 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

  • Lori F, Kelly LM, Lisziewicz J. APC-targeted immunization for the treatment of HIV-1. Expert Rev Vaccines. 2004 Aug;3(4 Suppl):S189-98. doi: 10.1586/14760584.3.4.s189.

    PubMed 15285717

  • Foli A, Maserati R, Barasolo G, Castelli F, Tomasoni L, Migliorino M, Maggiolo F, Pan A, Paolucci S, Scudeller L, Tinelli C, D'Aquila R, Lisziewicz J, Lori F. Strategies to decrease viral load rebound, and prevent loss of CD4 and onset of resistance during structured treatment interruptions. Antivir Ther. 2004 Feb;9(1):123-32.

    PubMed 15040544

  • Lisziewicz J, Bakare N, Lori F. Therapeutic vaccination for future management of HIV/AIDS. Vaccine. 2003 Jan 30;21(7-8):620-3. doi: 10.1016/s0264-410x(02)00569-8.

    PubMed 12531329

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infection, run by Genetic Immunity at 1 site in Italy.

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 8 Feb 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 Italy. 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.

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?

HIV-specific memory T cells measured as PHPC count (time frame: 9 week). 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 NCT00918840, which also lists 14 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 8 Feb 2013.

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