CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
one injection of vCP1452 at W0, W4, W8 and W20 +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00219362
NCT00219362Phase 2Completed

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

Objectif Recherche Vaccins SIDA·interventional·Posted Sep 22, 2005·Updated Nov 25, 2009

In Brief

A Phase 2 clinical trial evaluating one injection of vCP1452 at W0, W4, W8 and W20, one injection of vCP1452 at W4, W8 and W20, and 1 other intervention for HIV Infection. Completed, enrolled 65 participants across 5 sites in 4 countries.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection
CountriesFrance, Germany, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartApr 1, 2004
Primary CompletionNov 1, 2005
Study CompletionSep 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 20.8 years ago

Interventions

one injection of vCP1452 at W0, W4, W8 and W20biological

one injection of vCP1452 at W4, W8 and W20biological

one injection of placebo at W0, W4, W8, W20 or at W4, W8,W20biological