Phase 1 N=9 Treatment

Single DermaVir Immunization in HIV-1 Infected Patients on HAART

HIV Infection

Bottom Line

View on ClinicalTrials.gov: NCT00712530 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2013

Primary outcome: Primary: Grade 3 Adverse Event Related to DermaVir Treatment — 0; 0; 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: DermaVir (Biological); HAART (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Genetic Immunity
Primary completion: Jun 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Grade 3 Adverse Event Related to DermaVir Treatment	0; 0; 0	—
SECONDARY CD4+ T Cell Counts/mm3	893; 845; 621	—
SECONDARY Number of Subjects With Detectable Anti-ds Antibody and ANA	0; 0; 0	—
SECONDARY Number of Subjects Having More Than 50 Copies/mL HIV RNA	0; 0; 0	—
SECONDARY Change in HIV-specific Memory T Cell Responses at Day 28 Compare to Baseline	325; 136202; 50759	—

Summary

* DermaVir is a plasmid DNA-containing synthetic nanomedicine. It is administered topically with DermaPrep to target Langerhans cells. Langerhans cells with DermaVir migrate to lymph nodes and express HIV-like particles that induce immune responses to kill HIV-infected cells. * Hypothesis: Single DermaVir immunization is safe and immunogenic measured by induction of HIV-specific precursor/memory T cell responses. * GIHU004 was a phase I dose escalation study conducted in Hungary. It evaluated the safety and immunogenicity of three dosing regimens of topical DermaVir immunization for the treatment of HIV-infected individuals on fully suppressive highly active antiretroviral therapy (HAART).

Eligibility Criteria

Inclusion Criteria

Ability and willingness of subject or legal guardian/representative to give written informed consent
HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA
On a stable antiretroviral regimen without changes or interruptions for at least 12 weeks prior to study entry
Plasma HIV-1 RNA level of less than 50 copies/mL, obtained at least twice within the 12 weeks prior to study entry
Peak plasma HIV-1 RNA level before initiation of HAART > 1000 copies/mL
CD4 cell count > 300 cells/mm3 within the 12 weeks prior to study entry
Nadir (lowest) CD4+ cell count > 250 cells/mm3 at any time prior to study entry
The following laboratory values, obtained within 30 days prior to study entry:
Absolute neutrophil count (ANC) > 1000/mm3
Hemoglobin > 9.0 g/dL
Platelet count > 50,000/mm3
Serum creatinine 90 within 30 days prior to study entry
Men and women age 18-50 years

Exclusion Criteria

Viral load measurement > 50 copies/mL within the last 12 weeks prior to study entry
History of or evidence of active skin disease (e.g. atopic dermatitis), chronic autoimmune disease or any other significant active skin disease
Treatment with topical corticosteroids in close proximity to the proposed vaccination sites within 2 weeks prior to study entry
Excessive exposure to the sun (e.g. sunbathing) within 2 weeks prior to study entry
Use of any local skin treatments to the targeted vaccination sites within 7 days prior to study entry
History of diabetes and bleeding disorders
Previous CDC category C event
Pregnancy or breast-feeding
Use of immunomodulating therapy, including cyclosporin, IgG-containing products, interleukins, interferons, systemic glucocorticosteroids, or exposure to an experimental HIV vaccine within 6 months prior to study entry
Receipt of any vaccine within 30 days prior to study entry
Allergy/sensitivity to study vaccine products, including adhesives, will be excluded
Active drug or alcohol use or dependence
Serious illness until subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 14 days prior to study entry
Hepatitis B surface antigen and/or anti-hepatitis C positive

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00712530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.