Evidence map›Paper›PMID 31429785›Full record

Trial reportMalaria journal2019

Efficacy and safety of dihydroartemisinin-piperaquine for treatment of Plasmodium falciparum uncomplicated malaria in adult patients on antiretroviral therapy in Malawi and Mozambique: an open label non-randomized interventional trial.

Esperança Sevene, Clifford G Banda, Mavuto Mukaka, Sonia Maculuve, Salésio Macuacua, Anifa Vala, Mireia Piqueras, Linda Kalilani-Phiri, Jane Mallewa, Dianne J Terlouw and 3 more

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in Malaria journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
3.3field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 5 countries.

Esperança SeveneCentro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique. esevene68@gmail.com.
Clifford G BandaUniversity of Malawi, College of Medicine, Blantyre, Malawi.
Mavuto MukakaUniversity of Malawi, College of Medicine, Blantyre, Malawi.
Sonia MaculuveCentro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.
Salésio MacuacuaCentro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.
Anifa ValaCentro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.
Mireia PiquerasInstitute for Global Health, Universitat de Barcelona, Barcelona, Spain.
Linda Kalilani-PhiriUniversity of Malawi, College of Medicine, Blantyre, Malawi.
Jane MallewaUniversity of Malawi, College of Medicine, Blantyre, Malawi.
Dianne J TerlouwUniversity of Malawi, College of Medicine, Blantyre, Malawi.
Saye H KhooUniversity of Liverpool, Liverpool, UK.
David G LallooLiverpool School of Tropical Medicine, Liverpool, UK.
Victor MwapasaUniversity of Malawi, College of Medicine, Blantyre, Malawi. vmwapasa69@gmail.com.
Manhiça Health Research Centre · MZLiverpool School of Tropical Medicine · GBUniversity of Liverpool · GBMahidol Oxford Tropical Medicine Research Unit · THMalawi-Liverpool-Wellcome Trust Clinical Research Programme · MWRoyal Liverpool University Hospital · GBUniversitat de Barcelona · ESUniversity of Malawi · MW

Funding

European and Developing Countries Clinical Trials Partnership IP.07.31060.003Medical Research Council MR/L006758/1
6 · The paper itself

Abstract

backgroundHIV-infected individuals on antiretroviral therapy (ART) require treatment with artemisinin-based combination therapy (ACT) when infected with malaria. Dihydroartemisinin-piperaquine (DPQ) is recommended for treatment of Plasmodium falciparum malaria, but its efficacy and safety has not been evaluated in HIV-infected individuals on ART, among whom drug-drug interactions are expected. Day-42 adequate clinical and parasitological response (ACPR) and incidence of adverse events were assessed in HIV-infected individuals on non-nucleoside reverse transcriptase inhibitor-based ART (efavirenz and nevirapine) with uncomplicated P. falciparum malaria treated with dihydroartemisinin-piperaquine.

methodsAn open label single arm clinical trial was conducted in Malawi (Blantyre and Chikhwawa districts) and Mozambique (Manhiça district) involving patients aged 15-65 years with uncomplicated P. falciparum malaria who were on efavirenz-based or nevirapine-based ART. They received a directly-observed 3-day standard treatment of DPQ and were followed up until day 63 for malaria infection and adverse events. Day-42 PCR-corrected-ACPRs (95% confidence interval [CI]) were calculated for the intention-to-treat (ITT) population.

resultsThe study enrolled 160 and 61 patients on efavirenz and nevirapine-based ART, with a baseline geometric mean (95% CI) parasite density of 2681 (1964-3661) and 9819 (6606-14,593) parasites/µL, respectively. The day-42 PCR-corrected ACPR (95% CI) was 99.4% (95.6-99.9%) in the efavirenz group and 100% in the nevirapine group. Serious adverse events occurred in 5.0% (8/160) and 3.3% (2/61) of the participants in the efavirenz and nevirapine group, respectively, but none were definitively attributable to DPQ. Cases of prolonged QT interval (> 60 ms from baseline) occurred in 31.2% (48/154) and 13.3% (8/60) of the patients on the efavirenz and nevirapine ART groups, respectively. These were not clinically significant and resolved spontaneously over time. As this study was not designed to compare the efficacy and safety of DPQ in the two ART groups, no formal statistical comparisons were made between the two ART groups.

conclusionsDPQ was highly efficacious and safe for the treatment of malaria in HIV-infected patients concurrently taking efavirenz- or nevirapine-based ART, despite known pharmacokinetic interactions between dihydroartemisinin-piperaquine and efavirenz- or nevirapine-based ART regimens. Trial registration Pan African Clinical Trials Registry (PACTR): PACTR201311000659400. Registered on 4 October 2013, https://pactr.samrc.ac.za/Search.aspx.

Indexed as

AdolescentAdultAlkynesAntimalarialsAnti-Retroviral AgentsArtemisininsBenzoxazinesCyclopropanesDrug CombinationsFemaleHumansMalaria, FalciparumMalawiMaleMiddle AgedMozambiqueAlkynesAntimalarialsAnti-Retroviral AgentsArtemisininsartenimolBenzoxazinesCyclopropanesDrug CombinationsefavirenzNevirapinepiperaquinePiperazinesQuinolinesAntiretroviral drugsDihydroartemisinin–piperaquineDrug–drug interactionsHuman immunodeficiency virusMalaria

Identifiers

PMID31429785
PMCPMC6700797
OpenAlexW2969276370

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.