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Pharmacokinetic modeling of dolutegravir in HIV patients.
Proposal
982
Title of Proposed Research
Pharmacokinetic modeling of dolutegravir in HIV patients.
Lead Researcher
V P Subramanyam Rallabandi
Affiliation
National Brain Research Centre
Manesar, Haryana, Gurgaon, IN
Funding Source
None
Potential Conflicts of Interest
None
Data Sharing Agreement Date
31 May 2014
Lay Summary
In recent years, pharmacokinetic (PK) modelling has become a key factor in modern drug discovery and development. The use of Pharmacokinetic modelling in translational drug research is a promising approach that provides better understanding of the underlying kinetic phenomena involved with the study of absorption, distribution, metabolism and excretion of drugs. There are continuing efforts to develop the PK model in order to optimize therapy. Few studies were reported on clinical pharmacokinetics of dolutegravir (ML Cottrell et.al, 2013; IH Song et.al, ?2013.).A PK model of dolutegravir was not fully established in the literature. Developing a highly established PK model of dolutegravir is the objective of this research.
HIV/AIDS is a global pandemic. As of 2012, approximately 35.3 million people are living with HIV globally. Sub-Saharan African is the region most affected. Approximately 2.5 million cases are reported in India. According to WHO statics 2012, 1.6 million people died of AIDS-related illnesses. Though conventional therapies of HIV are in place, scientists are in search of new targets for effective HIV treatment. Dolutegravir (DTG) is an FDA-approved drug for the treatment of HIV infection. Dolutegravir is an integrase inhibitor. Drugs like raltegravir ,having similar mode of action were also approve by FDA and are in clinical use. A well-established pharmacokinetic model for raltegravir was reported in literature(L Wang Et.al,?2011).Developing a pharmacokinetic model provides better understanding of the underlying kinetic phenomena involved with the study of absorption, distribution, metabolism and excretion of drugs. There are continuing efforts to develop the PK model in order to optimize therapy. Hence there is a quick need for development of a well-established PK model for dolutegravir.
Study Data Provided
[{ "PostingID": 1383, "Title": "VIIV-ING111521", "Description": "A Phase 2a, Multicenter, Randomized, Parallel, Double-Blind, Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK1349572 Monotherapy Versus Placebo Over 10 days in HIV-1 Infected Adults (ING111521)
Medicine: dolutegravir, Condition: Infection, Human Immunodeficiency Virus, Phase: 2, Clinical Study ID: ING111521, Sponsor: ViiV" }]
Statistical Analysis Plan
The statistical analysis plan will be added after the research is published.
Publication Citation
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