Re-boosting of HIV-1 Infected Subjects With Vacc-4x

Completed · Phase 2

Conditions studied: HIV-1 Infection

In brief

During the course of HIV infection the number of CD4 cells decreases, resulting in a reduced immunological response and eventually immune deficiency. Vacc-4x is a peptide-based HIV immunotherapy vaccine and is anticipated to strengthen the immune system's response to HIV. All patients participating in this trial have previously received the vacc-4x vaccine in order to reduce the amount of HIV-1 virus in the blood and increase the immune response. The primary objective of this study is to evaluate if a re-boost with Vacc-4x could further reduce the amount of HIV-1 virus and increase the immune response.

Key facts

Study ID

NCT01712256

Run by

Bionor Immuno AS

People needed

33

Starts

2012-12-01

Expected to finish

2014-01-01

Last updated by the study team

2017-03-06

Who can join

Age: 18 and older, up to 63. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completed immunization regimen with Vacc-4x active and stopped ART (at Week 28) in the CT-BI Vacc-4x 2007/1 study. (No re-start of ART is required).
• Documented pre-study CD4 cell count ≥400x106/L.
• Documented pre-study viral load < 300 000copies/mL.
• Signed informed consent.

You may not qualify if…

• Reported AIDS-defining illness within the previous year.
• Malignant disease.
• On chronic treatment with immune-suppressive therapy.
• Unacceptable values of the hematologic and clinical chemistry parameters, as judged by the Investigator, including creatinine values >1.5 x upper limit of normal (ULN), and AST, ALT and alkaline phosphatase (ALP) values >2.5 x ULN.
• Concurrent chronic active infection such as viral hepatitis B or C or tuberculosis.
• Pregnant or breastfeeding women.
• Women of childbearing 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; sterile) during the 5 weeks re-boosting period including the DTH and for 2 weeks after the DTH test, or sexually active male subjects with partners of child bearing potential unwilling to practice effective contraception during the 5 weeks re-boosting period including the DTH and for 12 weeks after the DTH-test.
• Current participation in other clinical therapeutic studies.
• Incapability of compliance to treatment protocol, in the opinion of the Investigator.

Where it is running

• UCLA CARE Center — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I; Immunologische Ambulanz, Siegmund-Freud-Str. 25 — Bonn, Bonn, Germany
• ifi - Studien und Projekte GmbH, an der Asklepios-Klinik St. George — Hamburg, Free and Hanseatic City of Hamburg, Germany
• EIPMED - Gesellschaft fűr epidemiologische und klinische Forschung in der Medizin mbH Rubensstrasse 125 — Berlin, State of Berlin, Germany
• Universitätsklinikum Hamburg Eppendorf — Hamburg, Germany
• Istituto San Raffaele — Milan, Milano, Italy
• Hospital Germans Trias i Pujol — Badalona, Spain
• Unidad de VIH, Hospital de Bellvitge, Calle Feixa Llarga s/n, Hospitalet de Llobregat. — Barcelona, Spain
• Harrison Wing St Thomas' Hospital — London, London, United Kingdom

Full record on ClinicalTrials.gov

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