Immunogenicity and Safety of 2 Schedules of ALVAC-HIV vCP1452 in Chronically HIV-Infected Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: HIV Infection

In brief

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 plateau or a decrease of these responses prior to interrupting therapy. The goal of the present study is to look for an improved vaccination schedule in terms of strength and duration of the HIV-specific immunity induced by the HIV-recombinant canary pox vector ALVAC-HIV (vCP1452) by testing a strategy of immunization involving a first series of two versus three monthly injections followed by a boost three months later.

Key facts

Study ID: NCT00219362
Run by: Objectif Recherche Vaccins SIDA
People needed: 65
Starts: 2004-04-01
Expected to finish: 2006-09-01
Last updated by the study team: 2009-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Antiretroviral therapy started with CD4 cell count > 400/mm3
Patients treated at time of primary HIV infection
Patient with past AIDS defining event

Where it is running

Northwestern University Medical School — Chicago, Illinois, United States
Service des maladies infectieuses et tropicales, Hopital Pitié-Salpétrière, Pavillon Laveran — Paris, France
Klinikum der Johann Nolfgang Goethe Universitat Zentrum des Innerin Medizin — Frankfurt am Main, Germany
Fundacio Irsi Caixa Retrovirology Laboratory, Hospital Universitari Germans — Badalona, Spain
Servicios de Infecciosos, Hospital y clinic Provincial — Barcelona, Spain

Full record on ClinicalTrials.gov

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