Overview

This trial is active, not recruiting.

Condition hiv infection
Treatments dermavir, placebo
Phase phase 2
Sponsor Genetic Immunity
Collaborator Universitätsklinikum Hamburg-Eppendorf
Start date April 2008
End date December 2011
Trial size 36 participants
Trial identifier NCT00711230, 2007-001955-20, DermaVir Phase II

Summary

DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a single plasmid DNA expressing fifteen HIV antigens that assemble to HIV-like particles. These particles are safe; replication, integration and reverse transcription deficient. DermaVir is targeted to Langerhans cells by topical administration with DermaPrep. Langerhans cells with DermaVir migrate to lymph nodes and induce HIV-specific T cells that can kill HIV-infected cells.

GIEU006 is a Phase II randomized, placebo-controlled, dose-finding, double-blinded, multicenter study to assess the safety, tolerability, immunogenicity, and preliminary antiretroviral activity of DermaVir in antiretroviral therapy naïve adults with HIV-infection.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Dosage: 0.2 mg DNA Dosage form: 1.6 mL DNA/PEIm nanomedicine Administration with 2 DermaPrep patches Frequency: every six weeks Duration: 18 weeks (4 DermaVir treatments)
dermavir LC002
(Experimental)
Dosage form: 1.6 mL Placebo Administration with 2 DermaPrep patches Frequency: every six weeks Duration: 18 weeks (4 Placebo treatments)
placebo Placebo
glucose/dextrose
(Experimental)
Dosage: 0.4 mg DNA Dosage form: 3.2 mL DNA/PEIm nanomedicine Administration with 4 DermaPrep patches Frequency: every six weeks Duration: 18 weeks (4 DermaVir treatments)
dermavir LC002
(Experimental)
Dosage form: 1.6 mL Placebo Administration with 4 DermaPrep patches Frequency: every six weeks Duration: 18 weeks (4 Placebo treatments)
placebo Placebo
glucose/dextrose
(Experimental)
Dosage: 0.8 mg DNA Dosage form: 6.4 mL DNA/PEIm nanomedicine Administration with 8 DermaPrep patches Frequency: every six weeks Duration: 18 weeks (4 DermaVir treatments)
dermavir LC002
(Experimental)
Dosage form: 6.4 mL Placebo Administration with 8 DermaPrep patches Frequency: every six weeks Duration: 18 weeks (4 Placebo treatments)
placebo Placebo
glucose/dextrose

Primary Outcomes

Measure
Percent of participants with primary safety endpoint
time frame: 24 weeks

Secondary Outcomes

Measure
HIV-1 RNA
time frame: 24 weeks
CD4+ and CD8+ T-cell counts
time frame: 24 weeks
HIV-specific memory T cell responses
time frame: 24 weeks

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

Main inclusion Criteria: - HIV antibody positive - Plasma HIV RNA value ≥5,000 copies/mL and ≤ 150,000 c/mL - Antiretroviral therapy naïve - Documented CD4+ T-cell count at screening ≥400 cells/mm3 Main exclusion Criteria: - No skin disease - No tattoos, or changes in pigmentation at the selected skin immunization sites - No acute or chronic illness (e.g Hepatitis C) - No chronic autoimmune diseases - No treatment with any immune modulating agents

Additional Information

Official title A Phase II Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Safety, Tolerability, Immunogenicity, and Antiretroviral Activity of DermaVir Patch (LC002) in Treatment-Naïve HIV-1-Infected Patients
Principal investigator Jan Van Lunzen, PhD, MD
Description Patients were randomized into one of the following 6 arms: - Arm 1: Low dose DermaVir (0.2 mg DNA in 2 DermaPrep patches, n=9) - Arm 2: Low dose Placebo (2 DermaPrep patches, n=3) - Arm 3: Medium dose DermaVir (0.4 mg DNA in 4 DermaPrep patches, n=9) - Arm 4: Medium dose Placebo (4 DermaPrep patches, n=3) - Arm 5: High dose DermaVir (0.8 mg DNA in 8 DermaPrep patches, n=9) - Arm 6: High dose Placebo (8 DermaPrep patches, n=3) DermaPrep Patch size: 80 cm2. DermaVir Standard Unit per patch is 0.1 mg DNA = 0.8 mL of DermaVir nanomedicine. The patch sites for immunization are preferably the left or right upper back and left or right upper ventral thigh. The same skin sites should be used for all immunizations. Immunization schedule (Days): 0, 42, 84, and 126. The total DermaVir dose: - Low dose: 0.8 mg DNA - Medium dose: 1.6 mg DNA - High Dose: 3.2 mg DNA DermaVir immunizations were administered over an 18-week period Primary endpoint: 24 weeks Safety follow up: 234 weeks
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Genetic Immunity.