HIV Infection
Conditions
Keywords
HIV, Vaccine, Immune Therapy, DermaVir, Treatment experienced
Brief 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 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.
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
Interventions
BIOLOGICALDermaVir
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
BIOLOGICALPlacebo
Dextrose/glucose solution
DRUGHAART
Three or more antiretroviral drugs that can fully suppress HIV RNA
Sponsors
ViroStatics srl
Fondazione IRCCS Policlinico San Matteo di Pavia
Genetic Immunity
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV-specific memory T cells measured as PHPC count | 9 week | DermaVir-induced PHPC count compared to Placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV-1 RNA | weeks 16 and 20 | HIV-1 RNA set-point after analytical treatment interruption |
| CD4+ and CD8+ T cell counts | 20 weeks | — |
| Adverse Events | 20 weeks | — |
Countries
Italy
Outcome results
None listed