A Phase II, Randomized,Double-blind,Multicenter,Immunogenecity Study of Vacc-4x Versus Placebo in Patients Infected with HIV-1 Who Have Maintained an Adequate Response to ART - CT BI-Vacc-4x 2007/1

Conditions: HIV-1 infection
MedDRA version: 9.1Level: LLTClassification code 10003582Term: Asymptomatic human immunodeficiency virus type I infection

Registration Number: EUCTR2007-006302-13-IT

Lead Sponsor: BIONOR IMMUNO AS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 345

Inclusion Criteria

HIV positive for at least 1 year, stable on ART for the last 6 months,18-55 years old,viral load less then 50 copies/ml for the last 6 months,have a pre-study CD4 count more or equal 400x10 6 /l, a nadir CD4 count more or equal 200 x 10 6 /l,informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Reported pre-study AIDS defining clinical complications,malignant disease,on chronic treatment with immune-supressive therapy,unacceptable values of the hematologic and clinical chemistry parameters,concurrent chronic active infection,pregnant or breastfeeding woman,woman of childbearing potential not using adequate contraceptive methods.participation in other clinical therapeutic studies, incapable of compliance to the protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of Vacc-4x immunizations versus placebo on CD4 counts, T cell function (ELISPOT and T-cell proliferation assay), and the response to interruption of ART (changes in CD4 counts, rate of CD4 decline,viral load, and the proportion of subjects restarting ART within 24 weeks after stopping ART).;Secondary Objective: To evaluate the safety and tolerability of Vacc-4x To evaluate the immunogenecity of Vacc-4x by evaluation of DTH and to compare the DTH response to immunologic endpoints to CD4 changes during the 24-week ART free period To evaluate the effect of Vacc-4x on CD8 counts and HIV viral RNA To compare time to restart of ART for Vacc-4x treated subjects versus placebo;Primary end point(s): The proportion of the subjects who require resumption of ART betwwen the interruption of ART at week 28 and the end of the study at week 52

Secondary Outcome Measures