Status:
COMPLETED
Antiretroviral-Sparing Concept With HIV-specific T Cell Precursors With High Proliferative Capacity (PHPC)
Lead Sponsor:
Genetic Immunity
Collaborating Sponsors:
ViroStatics srl
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
HIV Infection
Eligibility:
All Genders
18-55 years
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-speci...
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 (Wee...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00918840
Start Date
April 1 2009
End Date
June 1 2011
Last Update
February 8 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
IRCCS Policlinico S. Matteo
Pavia, Italy, 27100