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Sponsored by: |
Objectif Recherche Vaccins SIDA |
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Information provided by: | Objectif Recherche Vaccins SIDA |
ClinicalTrials.gov Identifier: | NCT00219362 |
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.
Condition | Intervention | Phase |
---|---|---|
HIV Infection |
Biological: one injection of vCP1452 at W0, W4, W8 and W20 Biological: one injection of vCP1452 at W4, W8 and W20 Biological: one injection of placebo at W0, W4, W8, W20 or at W4, W8,W20 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Randomized, Placebo-Controlled Study to Evaluate the Immunogenicity and the Safety of 2 Schedules of an Homologous Prime-Boost With the ALVAC-HIV vCP1452 in Chronically HIV-Infected Patients |
Estimated Enrollment: | 66 |
Study Start Date: | April 2004 |
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 by intramuscular injection :
Arm A: one injection of vCP1452 at W0, W4, W8 and W20 + HAART, for a total of 4 injections Arm B: one injection of vCP1452 at W4, W8 and W20 + HAART, for a total of 3 injections Arm C: one injection of placebo at W0, W4, W8 and W20 + HAART, for a total of 4 injections or at W4, W8 and W20 + HAART, for a total of 3 injections
Step II: Post immunization phase from W24 to W48, off HAART
Discontinuation of antiretroviral therapy (ARV) from W24 to W48 :
The ARV treatment interruption will be proposed at W24, 4 weeks after the last immunization, to patient who had completed their immunization phase and have CD4 cell counts > 350 cells/mm3 and HIV plasma RNA < 400 cp/ml.
In order to be able to evaluate the capacity of the immune response to reduce the viral replication, a period of 16 weeks of interruption is recommended from W24 to W40.
Resumption of antiretroviral therapy :
From W24 to W40 : During this 16 weeks period, in case of a decline of CD4 cell counts below 250 cells/mm3 or of a loss of CD4 greater than 50% of the baseline value, HAART will be restarted.
From W40 to W48 : HAART should be reintroduced if HIV-1 RNA levels > 50 000 cp/ml on 2 consecutive measurements at two weeks interval even if the CD4 counts are above 250 cells/mm3.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Northwestern University Medical School | |
Chicago, Illinois, United States, 60611 | |
France | |
Service des maladies infectieuses et tropicales, Hopital Pitié-Salpétrière, Pavillon Laveran | |
Paris, France, 75013 | |
Germany | |
Klinikum der Johann Nolfgang Goethe Universitat Zentrum des Innerin Medizin | |
Frankfurt am Main, Germany, 60590 | |
Spain | |
Fundacio Irsi Caixa Retrovirology Laboratory, Hospital Universitari Germans | |
Badalona, Spain, 08916 | |
Servicios de Infecciosos, Hospital y clinic Provincial | |
Barcelona, Spain, 08036 |
Study Chair: | Christine Katlama, MD | Services des maladies infectieuses et tropicales, Hopital de la Pitié-Salpétrière, Université Pierre et Marie Curie, INSERM U720 |
Study ID Numbers: | MANON 02 |
Study First Received: | September 16, 2005 |
Last Updated: | October 21, 2005 |
ClinicalTrials.gov Identifier: | NCT00219362 |
Health Authority: | France: Afssaps - French Health Products Safety Agency; United States: Food and Drug Administration; Spain: Spanish Agency of Medicines; Germany: Paul-Ehrlich-Institut |
HIV-1 infection therapeutic vaccine Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |