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Proposal 982

Title of the 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

28 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

Study ING111521: 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)

Statistical Analysis Plan

This will be added after the research is published.

Publication Citation