Status:
COMPLETED
Immunogenicity and Safety of 2 Schedules of ALVAC-HIV vCP1452 in Chronically HIV-Infected Patients
Lead Sponsor:
Objectif Recherche Vaccins SIDA
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Prior pilot studies have shown that four monthly injections of ALVAC-HIV (vCP1433) are immunogenic in 60% HIV-infected patients with a boosting effect obtained after 1 or 2 injections followed by a pl...
Detailed Description
Manon 02 is a phase II, multicentre, randomized, placebo-controlled study with 3 arms comprising 2 steps: Step I : Immunization phase from W0 to W24, on HAART The immunization will be administered b...
Eligibility Criteria
Inclusion
- Documented HIV infection
- under potent antiretroviral therapy for more than 6 months
- with entry CD4+ counts \> 350 cells/mm3 for at least 1 year
- plasma HIV RNA \< 400 cp/ml for at least the last 6 months
- Contraception needed for women
Exclusion
- Antiretroviral therapy started with CD4 cell count \> 400/mm3
- Patients treated at time of primary HIV infection
- Patient with past AIDS defining event
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00219362
Start Date
April 1 2004
End Date
September 1 2006
Last Update
November 25 2009
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwestern University Medical School
Chicago, Illinois, United States, 60611
2
Service des maladies infectieuses et tropicales, Hopital Pitié-Salpétrière, Pavillon Laveran
Paris, France, 75013
3
Klinikum der Johann Nolfgang Goethe Universitat Zentrum des Innerin Medizin
Frankfurt am Main, Germany, 60590
4
Fundacio Irsi Caixa Retrovirology Laboratory, Hospital Universitari Germans
Badalona, Spain, 08916