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

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