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

NCT ID: NCT01218113

Last Updated: 2018-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 191 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-08
• Study Completion Date: 2012-11-05

Brief 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.

Conditions

AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

3D_HIV Group

HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.

Group Type: EXPERIMENTAL

GSK Biologicals HIV Vaccine 732462

Intervention Type: BIOLOGICAL

2 or 3 doses according to protocol schedule

2D_HIV Group

HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Group Type: EXPERIMENTAL

GSK Biologicals HIV Vaccine 732462

Intervention Type: BIOLOGICAL

2 or 3 doses according to protocol schedule

Placebo

Intervention Type: DRUG

1 or 3 doses according to protocol schedule

Control Group

HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 or 3 doses according to protocol schedule

Interventions

GSK Biologicals HIV Vaccine 732462

2 or 3 doses according to protocol schedule

Intervention Type: BIOLOGICAL

Placebo

1 or 3 doses according to protocol schedule

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Bakersfield, California, United States

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Washington D.C., District of Columbia, United States

GSK Investigational Site

Fort Lauderdale, Florida, United States

GSK Investigational Site

Jacksonville, Florida, United States

GSK Investigational Site

Orlando, Florida, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Camden, New Jersey, United States

GSK Investigational Site

Newark, New Jersey, United States

GSK Investigational Site

Somers Point, New Jersey, United States

GSK Investigational Site

Columbus, Ohio, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Johnson City, Tennessee, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Annandale, Virginia, United States

GSK Investigational Site

Seattle, Washington, United States

GSK Investigational Site

Bobigny, , France

GSK Investigational Site

Créteil, , France

GSK Investigational Site

Nantes, , France

GSK Investigational Site

Paris, , France

GSK Investigational Site

Paris, , France

GSK Investigational Site

Paris, , France

GSK Investigational Site

Paris, , France

GSK Investigational Site

Paris, , France

GSK Investigational Site

Paris, , France

GSK Investigational Site

Paris, , France

GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

GSK Investigational Site

Erlangen, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Bochum, North Rhine-Westphalia, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Badalona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Móstoles, Madrid, , Spain

GSK Investigational Site

Valencia, , Spain

Countries

United States; France; Germany; Spain

Other Identifiers

111679

Identifier Type: -

Identifier Source: org_study_id