Antiretroviral-Sparing Concept With HIV-specific T Cell Precursors With High Proliferative Capacity (PHPC) (PHPC-02)
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ClinicalTrials.gov Identifier: NCT00918840 |
Recruitment Status
:
Completed
First Posted
: June 11, 2009
Last Update Posted
: February 8, 2013
|
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Condition or disease | Intervention/treatment |
---|---|
HIV Infection | Biological: DermaVir Biological: Placebo Drug: HAART |
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
Study Type : | Observational |
Actual Enrollment : | 16 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | June 2011 |

Group/Cohort | Intervention/treatment |
---|---|
DermaVir + HAART
|
Biological: DermaVir
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
Other Name: LC002
Drug: HAART
Three or more antiretroviral drugs that can fully suppress HIV RNA
Other Name: Highly active antiretroviral therapy
|
Placebo + HAART
|
Biological: Placebo
Dextrose/glucose solution
Other Name: LC002 Placebo
Drug: HAART
Three or more antiretroviral drugs that can fully suppress HIV RNA
Other Name: Highly active antiretroviral therapy
|
- HIV-specific memory T cells measured as PHPC count [ Time Frame: 9 week ]DermaVir-induced PHPC count compared to Placebo
- HIV-1 RNA [ Time Frame: weeks 16 and 20 ]HIV-1 RNA set-point after analytical treatment interruption
- CD4+ and CD8+ T cell counts [ Time Frame: 20 weeks ]
- Adverse Events [ Time Frame: 20 weeks ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918840
Italy | |
IRCCS Policlinico S. Matteo | |
Pavia, Italy, 27100 |
Principal Investigator: | Renato Maserati, MD | IRCCS Policlinico S. Matteo | |
Study Chair: | Franco Lori, MD | ViroStatics srl |
Additional Information:
Publications:
Responsible Party: | Genetic Immunity |
ClinicalTrials.gov Identifier: | NCT00918840 History of Changes |
Other Study ID Numbers: |
PHPC-02 2008-003765-11 ( EudraCT Number ) |
First Posted: | June 11, 2009 Key Record Dates |
Last Update Posted: | February 8, 2013 |
Last Verified: | February 2013 |
Keywords provided by Genetic Immunity:
HIV Vaccine Immune Therapy DermaVir Treatment experienced |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |