Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01082692 | Study of PENNVAX™-B (Gag, Pol, Env) + Electroporation in HIV-1 Infected Adult Participants | PHASE1 | COMPLETED | 12 | — | — | Jan 1, 2011 | Aug 1, 2012 | Nov 9, 2012 | 1 | United States |
Frequency and severity of local and systemic reactogenicity signs and symptoms, laboratory measures of safety, including CD4 and HIV RNA viral load changes, and adverse and serious adverse events.
| Arm | Type | Description |
|---|---|---|
| 3mg DNA/dose | EXPERIMENTAL | Subjects will receive a 4 dose series of PENNVAX-B containing 3mg of DNA/dose administered via IM injection + electroporation at Day 0, Week 4, Week 8 and Week 16. |
| Name | Type | Description |
|---|---|---|
| PENNVAX-B | BIOLOGICAL | DNA plasmids delivered via IM injection + electroporation using CELLECTRA device |
Inclusion Criteria: * HIV-1 infection * On a stable HAART regimen for ≥3 months before the time of enrollment * CD4-+ lymphocyte count ≥400 cells/μL on two occasions within 60 days of enrollment * HIV-1 \< 75 copies/mL on two occasions within 60 days of enrollment * Body mass index (BMI) ≤30 kg/m\^...