NCT00614640 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Calarota SA, Weiner DB, Lori F, Lisziewicz J
Induction of HIV-specific memory T-cell responses by topical DermaVir vaccine. Vaccine. 2007 Apr 20;25(16):3070-4. Epub 2007 Jan 22.
Lisziewicz J, Calarota SA, Lori F
The potential of topical DNA vaccines adjuvanted by cytokines. Expert Opin Biol Ther. 2007 Oct;7(10):1563-74. Review.
Lori F, Weiner DB, Calarota SA, Kelly LM, Lisziewicz J
Cytokine-adjuvanted HIV-DNA vaccination strategies. Springer Semin Immunopathol. 2006 Nov;28(3):231-8. Epub 2006 Oct 20. Review.

A Phase I/II Study of the Safety, Tolerability, and Immunogenicity of a Topical Therapeutic DNA Dendritic Cell Vaccine (DermaVir Patch) in Children, Adolescents, and Young Adults With HIV-1 Infection on Highly Active Antiretroviral Therapy (HAART)

Details for clinical trial NCT00614640

Clinical trial NCT00614640 - References