Track topics on Twitter Track topics that are important to you
The purpose of the study is to see whether a single vaccination (injection) with the investigational HIV vaccine is safe and effective in patients who are HIV positive but have not yet begun anti-retroviral therapy. As this is an exploratory study, four different dose formulations of HIV vaccine will be investigated.
This study will evaluate whether or not the HIV vaccine is able to reduce the HIV viral load (number of HIV virus particles in the blood) and increase or slow the decline in CD4 T cell count.
The study will consist of a screening period of 3 to 21 days before vaccination on Day 0 and a double-blind treatment period of 28 days with a follow up period of 5 months. Prior to conducting any study-related procedures, subjects will provide written informed consent. During screening, eligibility will be assessed, a medical history will be taken, a complete physical examination will be performed and vital signs will be measured. Blood samples will be taken for the assessment of HCV and HBV status. Further samples will be taken for CD4 and HIV load, haematology, biochemistry, urinalysis and a 12-lead electrocardiographic (ECG) assessment will be carried out. A self-assessment diary card will be used by subjects between Day 0 and Day 28 to record any AEs.
On Days 7, 14, 21 and 28 an AE interview will be conducted, concomitant medications and vital signs will be recorded and a physical examination will be performed. Samples will be collected for haematology, clinical chemistry and urinalysis. In addition, samples will be collected for CD4 T cell count and HIV viral load at days 14 and 28 after vaccination. A sample will be collected for immunogenicity on Day 28.
All patients will attend follow-up visits at Weeks 8, 12, 16, 20 and 24 at which a physical examination and examination of the injection site will be performed and vital signs measured. Samples will be collected for haematology, biochemistry, urinalysis CD4 T-cell count and HIV viral load. Blood samples for immunogenicity testing will be collected at Weeks 12 and 24.
Stage I: Sequential, non-randomised, single blind, parallel group. Five male HIV-1 positive volunteers will be vaccinated in a sequential, non-randomised single blind fashion. They will each receive one of the five possible active study treatments (WFI only, adjuvant only, low dose + WFI, low dose + adjuvant, high dose + WFI and high dose + adjuvant). Each of these five patients will be observed as in-patients for 24 hours after vaccination and vaccinations will be performed in a sequential manner with at least 48 hours observation of each patient before vaccination of the next patient is commenced.
Following completion of the '28 day treatment follow up' by the five Stage I subjects a Safety Committee will review the safety and tolerability data for these subjects and will make a recommendation for continuing or discontinuing recruitment and any changes that may be required in the conduct of the study. Subject to a positive decision from the Safety Committee the remaining subjects will be recruited into Stage II of the study.
Stage II: randomised, double-blind group 50 male HIV-1 positive volunteers will be randomised to one of five possible treatment groups. Following completion of the Day 1 Visit by the first five subjects in Stage II the Safety Committee will review the blinded safety and tolerability data for these subjects. Subject to acceptable safety and tolerability, the centres will be allowed to continue recruitment for the rest of the planned cohort.
After 25 Stage II subjects have completed the Day 1 Visit a Safety Committee will review the blinded data generated and will make a recommendation for continuing or discontinuing recruitment and any changes that may be required in the conduct of the study.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
HIV-v (Low Dose), HIV-v (High Dose), HIV-v (Control)
Elton John Centre, Sussex House,
Published on BioPortfolio: 2014-08-27T03:15:49-0400
The purpose of this study is to evaluate the immunogenicity and safety of multiple formulations of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy women of child-bearing a...
The purpose of this study is to find out whether compared to our standard low dose ATG with CSA, the high dose ATG without CSA minimizes the chances of relapse and chronic GVHD, without in...
The purpose of this study is to evaluate the dose of High Dose Rate (HDR) brachytherapy chosen for this study as well as a commonly used alternate form of brachytherapy called low dose rat...
The purpose of this study is to evaluate the effectiveness of low dose dexamethasone versus high dose dexamethasone in the treatment of radiation induced vomiting.
This is a multicenter, randomized, open label study of high dose interleukin 2 vs high dose interleukin 2 plus entinostat in treatment-naïve clear cell RCC patients who are candidate for ...
Natural killer (NK) cells are vital components of the antiviral immune response, but their contributions in defense against influenza A virus (IAV) are not well understood. To better understand NK cel...
Stereotactic radiotherapy, which delivers an ablative high radiation dose to a target volume for maximum local tumor control, requires a rapid dose fall-off outside the target volume to prevent extens...
Which is better, high-dose metformin monotherapy or low-dose metformin/ linagliptin combination therapy, in improving glycemic variability in type 2 diabetes patients with insufficient glycemic control despite low-dose metformin monotherapy: A randomized, crossover, CGM-based, pilot study.
This study investigates the effect of high-dose metformin or low-dose metformin/linagliptin combination therapy on glycemic variability (GV) in type 2 diabetes (T2D) patients with insufficient glycemi...
International guidelines recommend high-dose cloxacillin for endocarditis or osteoarticular infections due to meticillin-susceptible staphylococci. However, data on the tolerability of these regimens ...
To examine whether a high-dose inactivated influenza vaccine was more efficacious in preventing hospitalizations than a standard-dose vaccine in the Veterans Health Administration (VHA) senior populat...
The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.
A treatment schedule in which the total dose of radiation is divided into large doses.
Mice selectively bred for hypersusceptibility to two-stage chemical skin carcinogenesis. They are also hypersusceptible to UV radiation tumorigenesis with single high-dose, but not chronic low-dose, exposures. SENCAR (SENsitive to CARcinogenesis) mice are used in research as an animal model for tumor production.
The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity. (from Lewis Dictionary of Toxicology, 1st ed)
The specific failure of a normally responsive individual to make an immune response to a known antigen. It results from previous contact with the antigen by an immunologically immature individual (fetus or neonate) or by an adult exposed to extreme high-dose or low-dose antigen, or by exposure to radiation, antimetabolites, antilymphocytic serum, etc.
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...
AIDS and HIV
AIDS; Acquired Immune Deficiency Syndrome. HIV; Human Immunodeficiency Virus HIV infection causes AIDS. HIV infection also causes the production of anti-HIV antibodies, which forms the test for HIV in patients. People who have the HIV antibodies are ...