Status:
COMPLETED
Dendritic Cell Vaccine in HIV-1 Infection
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
1. To study the efficacy of a therapeutic HIV vaccine consisting of autologous myeloid dendritic cells pulsed ex vivo with high doses of inactivated autologous HIV-1, in HIV-1 infected patients in a v...
Detailed Description
Our group has reported recently the first human trial of 4 therapeutic immunizations at six-week intervals with autologous monocyte-derived dendritic cells (MD-DC) loaded with heat-inactivated autolog...
Eligibility Criteria
Inclusion
- Confirmed HIV infection
- CD4 \> 450 x 10 6 /L
- baseline VL \>10,000 c/ml before any HAART
- Part I, patients off HAART at least during 6 months
- Part II, Patients on HAART with PVL \< 200 copies/ml at least during 6 months
- Written informed consent .
Exclusion
- Patients with failure to HAART
- Patients with B or C symptoms (CDC classification 1993).
- Age \< 18 years old.
- Pregnant or breastfeeding women
- Patients with baseline creatinin \> 2.5 mg/dl
- Patients with baseline GOT/GPT \> 250 UI/L
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00402142
Start Date
November 1 2006
End Date
December 1 2011
Last Update
February 26 2014
Active Locations (1)
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1
Hospital Clínic
Barcelona, Barcelona, Spain, 08036