Clinical trial NCT00918840: Antiretroviral-Sparing Concept With HIV-specific T Cell Precursors With High Proliferative Capacity (PHPC)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: HIV
Vaccine
Immune Therapy
DermaVir
Treatment experienced
Lead sponsor: Genetic Immunity
Sponsor class: INDUSTRY
Collaborators: name: ViroStatics srl
name: Fondazione IRCCS Policlinico San Matteo di Pavia
First posted: 2009-06-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

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

Eligibility 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

Primary outcomes:
measure: HIV-specific memory T cells measured as PHPC count
timeFrame: 9 week
Secondary outcomes:
measure: HIV-1 RNA
timeFrame: weeks 16 and 20
measure: CD4+ and CD8+ T cell counts
timeFrame: 20 weeks
measure: Adverse Events
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico S. Matteo
Study officials:
affiliation: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Renato Maserati, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ViroStatics srl
name: Franco Lori, MD
role: STUDY_CHAIR
References:
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