efficacy and safety of gsk biologicals hiv vaccine in antiretroviral therapy (art)-naïve hiv-1 infected persons

Conditions: AIDS

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

Keywords: human immunodeficiency virus (hiv)-1 safety vaccine immunogenicity reactogenicity hiv infection