Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV

Bionor Immuno

Status and phase: Completed; Phase 2

Conditions: HIV I Infection

Treatments: Drug: Vacc-4x; Drug: Sterile water

Study type: Interventional

Funder types: Industry

Identifiers

NCT00659789

13619 (Other Identifier)

2007-006302-13 (EudraCT Number)

CT-BI Vacc-4x 2007/1

Details and patient eligibility

About

Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore, ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure.

ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.

Full description

Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore,ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure.

ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.

Enrollment: 137 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-55
• HIV positive at least one year
• Clinically stable on ART for at least six months
• Documented viral load less than 50 copies/mL for the last six months
• Documented prestudy CD4 cell count equal or more than 400x10exp6/L
• Nadir CD4 cell count equal or more than 200x10exp6/L
• Signed informed consent

Exclusion criteria

• Reported pre-study AIDS-defining illness within the previous year
• Malignant disease
• On chronic treatment with immuno-suppressive therapy
• Unacceptable values of hematology and clinical chemistry parameters
• Current chronic infection such as HCV and HBV or active tuberculosis
• Pregnant or breastfeeding women
• Not using safe contraceptive methods
• Participation in other clinical trial
• Incapability of compliance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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137 participants in 2 patient groups, including a placebo group

Vacc-4x

Experimental group

Description:

Vacc-4x reconstituted in sterile water (0.1 mL) at a dose of 1.2mg per intradermal administration. Participants are given a total of 6 immunizations over 18 weeks (weeks 1, 2, 3, 4, 16, 18). Recombinant human granulocyte macrophage colony stimulating factor (rhuGM-CSF) Leukine (0.06mg in 0.1 mL) administered intradermally is used as a local adjuvant.

Treatment:

Drug: Vacc-4x

Placebo

Placebo Comparator group

Description:

Placebo injections consisting of sterile water (0.1 mL) in place of Vacc-4x. Placebo injections consisting of sterile water (0.1 mL) in place of Leukine.

Treatment:

Drug: Sterile water