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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genetic Immunity
• Collaborators: IRCCS Policlinico S. Matteo; ViroStatics srl
• Treatments: Anti-Retroviral Agents

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