NCT01260727 - 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)

Cristillo AD, Weiss D, Hudacik L, Restrepo S, Galmin L, Suschak J, Draghia-Akli R, Markham P, Pal R
Persistent antibody and T cell responses induced by HIV-1 DNA vaccine delivered by electroporation. Biochem Biophys Res Commun. 2008 Feb 1;366(1):29-35. Epub 2007 Nov 26.
Loutfy MR, Harris M, Raboud JM, Antoniou T, Kovacs C, Shen S, Dufresne S, Smaill F, Rouleau D, Rachlis A, Gough K, Lalonde R, Tsoukas C, Trottier B, Walmsley SL, Montaner JS
A large prospective study assessing injection site reactions, quality of life and preference in patients using the Biojector vs standard needles for enfuvirtide administration. HIV Med. 2007 Oct;8(7):427-32.

A Phase I Study of the Safety and Immunogenicity of PENNVAX-G DNA (ENV & GAG) Administered by Intramuscular Biojector 2000 or CELLECTRA Intramuscular Electroporation Device Followed by MVA-CMDR (HIV-1 CM235 ENV/CM240 GAG/POL) Boost in Healthy, HIV Uninfected Adults

Details for clinical trial NCT01260727

Clinical trial NCT01260727 - References