Efficacy and Safety of GSK Biologicals HIV Vaccine in Antiretroviral Therapy (ART)-naïve HIV-1 Infected Persons

Efficacy and Safety of HIV Vaccine 732462 in ART-naïve HIV-1 Infected Persons

This study is designed to determine whether administration of the GSK Biologicals HIV vaccine 732462 can lead to a reduction in viral load, and impact on the course of human immunodeficiency virus type 1 (HIV-1) infection. In HIV-1 infected persons who have not yet started antiretroviral therapy (ART), such a vaccine would potentially lead to a delay in the initiation of treatment.

Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

• Subjects who the investigator believes can and will comply with the requirements of the protocol.

• Written informed consent obtained from the subject prior to any study procedure.

• A male or female between and including 18-55 years at the time of first vaccination.

• Known to be HIV-1 infected and under the care of an HIV physician for a minimum of 6 months. However, subjects who initially presented with a clinical diagnosis of primary HIV infection need to have been diagnosed and under care for at least 12 months.

• ART-naïve. Individuals must never have received ART after HIV diagnosis, including lamivudine used for chronic hepatitis B infection, with the exception of short-term ART for prevention of mother-to-child transmission (PMTCT) at least 12 months prior to enrollment.

• Commencement of ART is not expected, based on current assessment, within the next 12 months.

• Viral load level of 2,000-80,000 copies/mL at screening.

• CD4 count >= 500 cells per mm3 at screening.

• If the subject is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal. Female subjects of childbearing potential may be enrolled in the study, if the subject:

  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test at screening, and
  • has agreed to continue adequate contraception during the entire study period.

Exclusion Criteria:

The following criteria should be checked at the time of screening and before vaccination. If ANY exclusion criterion applies, the subject must not be included in the study:

• Infection with HIV-2. This includes patients with dual infection with HIV-1/HIV-2.

• Had an Acquired Immune Deficiency Syndrome (AIDS) defining clinical illness.

• Use of any investigational or non-registered product within 4 weeks preceding the first dose of study vaccine/placebo, or planned use of any investigational or non-registered product other than the study vaccine during the study period.

• Drug therapy with immunomodulators or steroids within the 12 weeks preceding the first dose of study vaccine/placebo or planned administration during the study period. Acute use of steroids up to 4 weeks preceding the first dose for treatment of hypersensitivity reactions is not an exclusion criterion. Inhaled and topical steroids are allowed.

• Administration of immunoglobulins and/ or any blood products within the 12 weeks preceding the first dose of study vaccine/placebo or planned administration during the study period.

• Planned administration of a vaccine not foreseen by the study protocol during

  • the period starting 2 weeks before the first dose of study vaccine/placebo and ending at Visit 3 (Week 6) (after blood sampling),
  • the period starting from 2 weeks prior to Visit 5 (Week 28) and ending at Visit 6 (Week 30) (after blood sampling)
  • the period starting from 2 weeks prior to Visit 8 (Week 48) and ending at Visit 8 (Week 48) (after blood sampling), with the exception of non-adjuvanted influenza vaccine.

• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

• Any previous vaccination or immunotherapy against HIV.

• A family history of hereditary immunodeficiency.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

• Acute or chronic infective hepatitis.

• Acute or chronic, clinically relevant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination and/or medical history at screening.

• Grade 3 or grade 4 laboratory abnormality, as defined by Division od AIDS (DAIDS) grading table, at screening

• Pregnant or lactating female.

• Any condition which, in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol.

• History of medically confirmed autoimmune disease.

• History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure.

• Unstable asthma

• Food or wine induced asthma.

• Known sensitivity to sulfites or aspirin.

• Known sensitivity to aminoglycoside antibiotics.

• Contraindication to intramuscular injection