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This phase I study is the first step to determine if Opal immunotherapy may have potential utility as a treatment for HIV. Although effective treatments for HIV infection exist, they are limited by the requirement for life-long daily treatment, cost, side effects, and the development of resistance.
There is a need for therapeutic approaches that induce or enhance T-cell immunity to control HIV disease. Overlapping Peptide-pulsed Autologous Cells (Opal) is a technique where autologous peripheral blood mononuclear cells (PBMC) or whole blood is pulsed with sets of overlapping peptides spanning whole proteins of HIV.
Opal-HIV-Gag(c) is not for direct injection and is administered by ex vivo incubation of whole blood or separated blood components (such as white blood cells or peripheral blood mononuclear cells) and reinfusion.
As a practical alternative to PBMC separation and to optimise vaccine presentation during the ex vivo incubation, a blood cell separation device will be used to separate the whole blood and enrich the white blood cell component. The device processes whole blood in a closed, single use disposable kit. Reconstituted Opal-HIV-Gag(c)or matching placebo will be added to the white blood cells, incubated for one hour and reinfused into the subject. Subjects will receive 4 administrations at 4 weekly intervals. Subjects are followed for 12 weeks after the final administration.
Each dose group will be enrolled sequentially, with a sentinel group for each dose group. Satisfactory safety data from each cohort, reviewed by a Data Safety Monitoring Board, will permit dose escalation.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Opal-HIV-Gag(c) Low Dose, Opal-HIV-Gag(c) Medium dose, Opal-HIV-Gag(c) High dose, Dimethyl Sulfoxide
St Stephen's Centre, Chelsea and Westminster Foundation Trust
Medicines Development Limited
Published on BioPortfolio: 2014-08-27T03:13:40-0400
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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.
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)
Administration of the total dose of radiation (RADIATION DOSAGE) in parts, at timed intervals.
The ratio of the dose that produces toxicity to the dose that produces a clinically desired or effective response.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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