Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2009 Nov 30:8:272.
doi: 10.1186/1475-2875-8-272.

Safety and tolerability of artemether-lumefantrine versus dihydroartemisinin-piperaquine for malaria in young HIV-infected and uninfected children

Shereen Katrak  1 , Anne Gasasira, Emmanuel Arinaitwe, Abel Kakuru, Humphrey Wanzira, Victor Bigira, Taylor G Sandison, Jaco Homsy, Jordan W Tappero, Moses R Kamya, Grant Dorsey
Affiliations
Randomized Controlled Trial

Safety and tolerability of artemether-lumefantrine versus dihydroartemisinin-piperaquine for malaria in young HIV-infected and uninfected children

Shereen Katrak et al. Malar J. .

Abstract

Background: Artemisinin combination therapy has become the standard of care for uncomplicated malaria in most of Africa. However, there is limited data on the safety and tolerability of these drugs, especially in young children and patients co-infected with HIV.

Methods: A longitudinal, randomized controlled trial was conducted in a cohort of HIV-infected and uninfected children aged 4-22 months in Tororo, Uganda. Participants were randomized to treatment with artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DP) upon diagnosis of their first episode of uncomplicated malaria and received the same regimen for all subsequent episodes. Participants were actively monitored for adverse events for 28 days and then passively for up to 63 days after treatment. This study was registered in ClinicalTrials.gov (registration # NCT00527800).

Results: A total of 122 children were randomized to AL and 124 to DP, resulting in 412 and 425 treatments, respectively. Most adverse events were rare, with only cough, diarrhoea, vomiting, and anaemia occurring in more than 1% of treatments. There were no differences in the risk of these events between treatment groups. Younger age was associated with an increased risk of diarrhoea in both the AL and DP treatment arms. Retreatment for malaria within 17-28 days was associated with an increased risk of vomiting in the DP treatment arm (HR = 6.47, 95% CI 2.31-18.1, p < 0.001). There was no increase in the risk of diarrhoea or vomiting for children who were HIV-infected or on concomitant therapy with antiretrovirals or trimethoprim-sulphamethoxazole prophylaxis.

Conclusion: Both AL and DP were safe and well tolerated for the treatment of uncomplicated malaria in young HIV-infected and uninfected children.

Trial registration: ClinicalTrials.gov: NCT00527800; http://clinicaltrials.gov/ct2/show/NCT00527800.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Trial profile. Enrollment and randomization of study patients.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Bosman A, Mendis K. A major transition in malaria treatment: The adoption and deployment of artemisinin-based combination therapies. Am J Trop Med Hyg. 2007;77:193–197. - PubMed
    1. World Health Organization (WHO) Global AMDP Database-AFRO. 2008. http://www.who.int/malaria/amdp/amdp_afro.htm Accessed December 7, 2008.
    1. Kamya MR, Yeka A, Bukirwa H, Lugemwa M, Rwakimari JB, Staedke SG, Talisuna AO, Greenhouse B, Nosten F, Rosenthal PJ, Wabwire-Mangen F, Dorsey G. Artemether-lumefantrine versus dihydroartemisinin-piperaquine for treatment of malaria: A randomized trial. PLoS Clin Trials. 2007;2:e20. doi: 10.1371/journal.pctr.0020020. - DOI - PMC - PubMed
    1. Karema C, Fanello CI, van Overmeir C, van Geertruyden JP, van Doren W, Ngamije D, D'Alessandro U. Safety and efficacy of dihydroartemisinin/piperaquine (Artekin) for the treatment of uncomplicated Plasmodium falciparum malaria in Rwandan children. Trans R Soc Trop Med Hyg. 2006;100:1105–11. doi: 10.1016/j.trstmh.2006.01.001. - DOI - PubMed
    1. Myint HY, Ashley EA, Day NP, Nosten F, White NJ. Efficacy and safety of dihydroartemisinin-piperaquine. Trans R Soc Trop Med Hyg. 2007;101:858–66. doi: 10.1016/j.trstmh.2007.05.018. - DOI - PubMed

Publication types

MeSH terms

Associated data