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

Completed

• Conditions: HIV Infection
• Interventions: Biological: DermaVir; Biological: Placebo; Drug: HAART

• Registration Number: NCT00918840
• Lead Sponsor: Genetic Immunity

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

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-06-08
• Study First Submitted QC: 2009-06-10
• Study First Posted: 2009-06-11
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DermaVir + HAART	DermaVir	* Dosage: 0.4 mg DNA * Dosage form: 3.2 mL DNA/PEIm nanomedicine * Administration with 4 DermaPrep patches * Frequency: every 4 weeks * Duration: 8 weeks (3 DermaVir treatments)
Placebo + HAART	Placebo	* Dosage form: 3.2 mL Placebo * Administration with 4 DermaPrep patches * Frequency: every four weeks * Duration: 8 weeks (3 Placebo treatments)
DermaVir + HAART	HAART	* Dosage: 0.4 mg DNA * Dosage form: 3.2 mL DNA/PEIm nanomedicine * Administration with 4 DermaPrep patches * Frequency: every 4 weeks * Duration: 8 weeks (3 DermaVir treatments)
Placebo + HAART	HAART	* Dosage form: 3.2 mL Placebo * Administration with 4 DermaPrep patches * Frequency: every four weeks * Duration: 8 weeks (3 Placebo treatments)

Primary Outcome Measures

Name	Time	Method
HIV-specific memory T cells measured as PHPC count	9 week	DermaVir-induced PHPC count compared to Placebo

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

IRCCS Policlinico S. Matteo; 🇮🇹 Pavia, Italy