Efficacy and Safety of GSK Biologicals HIV Vaccine in Antiretroviral Therapy (ART)-naïve HIV-1 Infected Persons
Condition: AIDS
Intervention: GSK Biologicals HIV Vaccine 732462; Placebo
Intervention description: 2 or 3 doses according to protocol schedule; 1 or 3 doses according to protocol schedule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 191.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Human Immunodeficiency Virus (HIV)-1; safety; vaccine; immunogenicity; reactogenicity; HIV infection

Summary:

      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.
    

Eligibility criteria:

        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