About Global Health Pharmacology and Therapeutics (GH-Pharma)

Research

Our research is focused on tropical pharmacology - investigating genetic and environmental factors influencing between individuals and population variations in treatment response, including efficacy and susceptibility to adverse events such as drug induced liver and CNS toxicity.

We are working on treatment optimization of several communicable and non-communicable diseases including the three most deadly infectious diseases (HIV/AIDS, tuberculosis, and malaria), neglected tropical diseases, breast cancer and antimicrobial resistance that claim millions of lives worldwide, especially in sub Saharan Africa, where the disease burden is paramount and yet little is known about the impact of host-genetic factors, drug interactions, coinfections and comorbidity, and nutrition on both the safety and efficacy of therapy.

We are conducting several case-control, parallel comparative, prospective observational studies, randomized clinical trials, drug interaction and dose optimization studies in various patient cohorts including adult, children and pregnant women. For the past 20 years, we have been conducting several pharmacogenetics, pharmacokinetics, and pharmacodynamics, drug-drug interaction studies in well-characterized large prospective patient cohorts in East Africa (Ethiopia, Kenya, Tanzania, Uganda and Rwanda).

Through the PROFORMA project (http://proforma.ki.se/), we are currently conducting pharmacovigilance and post marketing surveillance of mass drug administration and vaccinations in Ethiopia, Kenya, Tanzania and Rwanda.  Through the PREGART project (https://www.pregart.eu/) we are investigating the safety and efficacy of Dolutegravir and EFV400 for pregnant and breastfeeding women: a randomized non-inferiority clinical trial in Uganda and Ethiopia. Our goal is to provide evidence-based recommendations for personalized medicine, and for policymakers to improve/revise treatment guidelines and global health policies.

Research areas

  1. Treatment optimization of HIV/AIDS, tuberculosis and malaria - 'The big three”
  2. Maternal and child health
  3. Neglected tropical diseases (diverse group of infectious diseases that are endemic in tropical and subtropical regions, such as schistosomiasis, leishmaniosis, onchocerciasis)
  4. Discovery and validation of novel genetic, metabolic and proteomic biomarker for drug induced liver toxicity
  5. Non-communicable diseases (breast cancer, diabetes, cardiovascular diseases)
  6. Antimicrobial resistance, community and hospital acquired infections.
  7. Pharmacovigilance and post-marketing surveillance in public health program involving mass-drug-administration and immunization.
     

External funding

European Union, H2020 - European and developing countries clinical trial partnership (EDCTP), Swedish research council, Swedish development cooperation agency (Sida), MSB-Swedish Civil Contingencies Agency, Astra-Zeneca

Current Ongoing Research projects

  1. Pharmacovigilance infrastructure and post-marketing surveillance system capacity building for regional medicine regulatory harmonization in East Africa- (Acronym - PROFORMA) (http://proforma.ki.se/).
     
  2. Safety and efficacy of Dolutegravir and EFV400 for pregnant and breastfeeding women: a randomized non-inferiority clinical trial (Acronym - PREGART) (https://www.pregart.eu/).
     
  3. Effectiveness dihydroartemisinin -piperaquine versus sulfadoxine-pyrimethamine for prevention of falciparum malaria infection during pregnancy in Tanzania.
     
  4. Randomized clinical trial to determine the efficacy and safety of Praziquantel combined with Dihydroartemisinin-Piperaquine versus Praziquantel alone for the treatment of schistosomiasis in Tanzania.
     
  5. Safety and efficacy surveillance of praziquantel and albendazole mass drug administration for prevention and treatment of schistosomiasis and soil transmitted helminths in Rwanda and Ethiopia.
     
  6. Active Safety and Efficacy Surveillance of Ivermectin and Albendazole for prevention and treatment of lymphatic filariasis in Tanzania.
     
  7. Active Surveillance of Ivermectin/Albendazole/ Diethylcarbamazine in Lymphatic Filariasis Control Program in the Coastal Region of Kenya.
     
  8. Factors affecting malaria treatment outcome among pregnant women treated with artemether-lumefantrine in Tanzania.
     
  9. Optimization of pediatric antiretroviral therapy in sub-Saharan Africa.
     
  10. Pharmacokinetics and Pharmacogenetics of Cyclophosphamide and tamoxifen for the treatment of Breast Cancer patients in Ethiopia.

Research techniques

  • Clinical research – Observational, Prospective Cohort studies, Cross sectional studies, randomized clinical trials, Case control studies, Drug interaction studies, etc
  • Biomarker discovery and validation
  • Pharmacogenetics - Genotyping, DNA sequencing, bioinformatics
  • Phenotyping - LC/MS/MS, GC/MS, HPLC
  • Pharmacokinetics
  • Pharmacodynamics
  • Quantitative PCR
  • Population PK-PD-PG modelling
  • Epigenetic studies

Teaching assignments

  • Research methodology,
  • Pharmacology Pharmacogenetics
  • Infectious diseases pharmacology
  • Antiretroviral pharmacology
  • Antimalarial drugs Pharmacology
Maja Rudolphson
23-08-2023