None listed
Conditions
Brief summary
The study will examine the possibility that dendritic cell immunotherapy might increase HCV-specific cell mediated immunity with a concomitant decrease in the viral load, or even viral clearance.
Interventions
Dendritic cell immunotherapy to elicit HCV-specific cell mediated immunity in patients who have previously failed interferon-based therapy. The dose will vary from 1 dose unit (DU) representing 10 million, HCV-specific peptide pulsed monocyte-derived dendritic cells, to 5 DU on 1, 2 or 3 occasions at weekly intervals. As this trial was a first in man, the dose variation was decided after consultation with the Therapeutic Goods Administration and was based on previous dendritic cell therapy cancer trials as follows: Patient #1-1 DU by the intravenous route and 1DU by the intradermal route. Patient #2-1DU by the intravenous route on 2 occasions, two weeks apart, accompanied by 1DU by the intradermal route on both occasions. Patient #3-1DU followed by 2DU and 5DU at 2 weekly intervals by the intravenous route, accompanied by 1DU by the intradermal route at each time point. Patient #4-1DU followed by 5DU at 2 weekly intervals by the intravenous route, accompanied by 1DU by the intradermal route at each time point. Patient #5-2DU on 3 occasions, 2 weeks apart by the intravenous route, accompanied by 1DU by the intradermal route at each time point. Patient #6-2DU on 3 occasions, 2 weeks apart by the intradermal route.
Sponsors
Study design
Eligibility
Inclusion criteria
HCV RNA positive for >6 months. Previously failed interferon-based therapy. Infected with genotype 1.
Exclusion criteria
Evidence of liver infection with other hepatitis agents, viz. HAV, HBV. HIV infection. Evidence of autoimmunity.