At a glance
ClinicalIndex Comparison Record- ✓HIV-1-infected
- ✓On stable HAART for ≥12 weeks with no interruptions >4 consecutive days, using ≥2 drug classes
- ✓Plasma HIV-1 viral load <50 copies/mL on two readings within 30 days before entry
- ✓CD4 count >350 cells/mm³ within 12 weeks before entry
- ✕HIV-1 viral load >500 copies/mL within 24 weeks before entry
- ✕History of or current active skin disease (atopic dermatitis, psoriasis) or chronic autoimmune disease (e.g., Graves' disease)
- ✕Topical corticosteroids at proposed vaccination sites within 2 weeks before entry
- ✕Excessive sun exposure or tanning within 2 weeks before entry
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of LC002, a DermaVir Vaccine, in HIV-1-Infected Subjects Currently Under Treatment With Highly Active Antiretroviral Therapy (HAART)
In Brief
A Phase 2 clinical trial evaluating LC002 standard vaccination, LC002 high-dose vaccination, and 1 other intervention for HIV Infections. Completed, enrolled 28 participants across 5 sites.
Detailed Summary
LC002 is an experimental therapeutic vaccine designed to boost the immune response of people infected with HIV. The purpose of this study was to determine the safety and tolerability of and immune response to LC002 in HIV-1-infected adults who are currently receiving anti-HIV treatment.
Study Details
Timeline
Interventions
0.1 mg DNA/participant, 0.8 ml total administered subcutaneously
0.4 mg DNA/participant, 3.2 ml total administered subcutaneously
Placebo vaccination administered subcutaneously