ACT-ARV Haematology Study Group

ACT-ARV Haematology Study Group

This is an extension of the WWARN Haemoglobin-Haematocrit Relationship in Malaria Study Group and the Antimalarial–Antiretroviral Analyses Study Group. These groups aimed to consider the effect of HIV disease and co-administration of widely-used antiretroviral drugs (ARVs) on artemisinin-based combination therapies (ACTs).  

Updates and overview

Data submissions have now closed, and a draft publication will be circulated to study group members in due course with submission expected in Q3 2019. 


In sub-Saharan Africa (SSA) where malaria is highly prevalent, HIV infection is also endemic. Co-infection and co-treatment of malaria and HIV are therefore frequent. Cases of transient anaemia observed when an ACT is administered during an episode of uncomplicated malaria infection have resulted in a debate on whether the changes in haemoglobin are due to toxicity of the ACT or a result of the malaria infection [1,2]. In addition, HIV-infection may be associated with increased risk of anaemia as a result of haemolysis and decreased red blood cell production [3-5]. Understanding any potential impact that malaria-infection, commonly used ARVs and ACTs may have on haemoglobin levels in the millions of HIV infected individuals living in sub-Saharan Africa, is an important step in optimising antimalarial treatment in this key vulnerable sub-population.


To understand factors associated with risk of moderate or severe anaemia in adults with HIV (and / or malaria infections treated with ACTs).

Inclusion criteria for data sets
  • Patient demographic characteristics (including age, gender, body weight);
  • Clinical studies in adult participants (aged 15+ years) with malaria AND / OR HIV infection that were enrolled in studies in sub-Saharan Africa;
    • If malaria infected: baseline parasite density
    • If applicable: ARV regimen
  • At least one ACT dose given (whether used for uncomplicated malaria treatment OR chemoprevention OR in healthy volunteers) with ACT regimen and dose.
  • Data available on haemoglobin recorded before ACT treatment and on at least one follow up visit on days: 3, 7, 14, 21, 28 and / or 42 (with allowance for +/– 1 day on the different visit days)
Data standardisation and analysis

After upload to the WWARN Data Repository, data sets will be transformed, standardised and combined according to the WWARN Pharmacology and Clinical Data Management and Statistical Analysis Plans. The statistician appointed to the project will develop a statistical analysis plan specifically for the meta-analysis, in collaboration with Study Group members.


Study Group governance and membership

The Study Group comprises participating investigators who contribute relevant data sets to the pooled analysis. Data sets remain the property of the investigator. The Study Group will be asked to assist in the identification of any further relevant studies and will collectively make decisions with respect to data analysis plans and plans for publication, in line with the WWARN Publication Policy. The Study Group will be led by Prof Karen I Barnes (Head WWARN Pharmacology Group) and Dr Clifford G Banda (WWARN & EDCTP Career Development Fellow), at the University of Cape Town. For further information, email Karen Barnes or


1. Harris RJ, Sterne JAC, Abgrall S, Dabis F, Reiss P, Saag M, et al. Prognostic importance of anaemia in HIV type-1-infected patients starting antiretroviral therapy: collaborative analysis of prospective cohort studies. Antivir Ther. NIH Public Access; 2008;13:959–67.
2. Naing C, Sandhu NK, Wai VN. The Effect of Malaria and HIV Co-Infection on Anemia: A Meta-Analysis. Medicine (Baltimore). Wolters Kluwer Health; 2016;95:e3205.
3. Sanyaolu AO, Fagbenro-Beyioku AF, Oyibo WA, Badaru OS, Onyeabor OS, Nnaemeka CI. Malaria and HIV co-infection and their effect on haemoglobin levels from three health-care institutions in Lagos, southwest Nigeria. Afr Health Sci. Makerere University Medical School; 2013;13:295–300.
4. Finaurini S, Ronzoni L, Colancecco A, Cattaneo A, Cappellini MD, Ward SA, et al. Selective toxicity of dihydroartemisinin on human CD34+ erythroid cell differentiation. Toxicology. 2010;276:128–34.
5. Zwang J, D ’alessandro U, Ndiaye J-L, Djimdé AA, Dorsey G, Mårtensson AA. Haemoglobin changes and risk of anaemia following treatment for uncomplicated falciparum malaria in sub-Saharan Africa. BMC Infect Dis. 2017;17.