A Phase II, Randomized, Double-Blind, Multicenter, Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected with HIV-1 Who Have Maintained an Adequate Response to ART

• Conditions: HIV positive subjects who have been clinically stable on antiretroviral therapy for the last six months with a viral load less than 50 copies/mL for the last six months and a CD4 cell count => 400 x 10^6/L and who meet the other inclusion and exclusion criteria of the protocol; MedDRA version: 12.0Level: LLTClassification code 10020161Term: HIV infection

• Registration Number: EUCTR2007-006302-13-GB
• Lead Sponsor: Bionor Immuno AS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-18
• Last Update Posted: 10 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Age between 18 and 55 years
2. HIV positive at least one year
3. Clinical stable on antiretroviral therapy for the last six months
4. Documented viral load less than 50 copies/mL for the last six months
5. Documented prestudy CD4 cell count => 400 x 10^6/L
6. Nadir (lowest ever) CD4 cell count => 200 x 10^6/L
7. Signed 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

1. Reported pre-study AIDS defining illness within the previous year (see Appendix 15.3 of protocol)
2. Malignant disease
3. On chronic treatment with immune suppressive therapy
4. Unacceptable values of the haematologic and clinical chemistry parameters, as judged by the Investigator or the Sponsor (or designee) including creatinine values > 1.5 x upper limit of norma and asparatate aminotransferase (SGOT), alanine aminotransferase (SGOT) and alkaline phosphatase values greater than 2.5 x upper limit of normal
5. Concurrent chronic active infection such as chronic viral hepatitis B or C or active tuberculosis
6. Pregnant or breast feeding women
7. Women of childbearning potential not using reliable and adequate contraceptive methods (defined as: use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; practicing abstinence or sterile) during the 18 week treatment period and for 2 weeks after the last immunization, or sexually active male patients with partners of child bearing potential unwilling to practice effective contraception during the 18 week treatment period and for 12 weeks after the last immunization.
8. Concurrent participation in other clinical therapeutic studies
9. Incapability of compliance to the treatment protocol, in the opinion of the Investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified