Evidence map›Paper›PMID 30789910›Full record

ArticlePLoS neglected tropical diseases2019

Long term outcomes and prognostics of visceral leishmaniasis in HIV infected patients with use of pentamidine as secondary prophylaxis based on CD4 level: a prospective cohort study in Ethiopia.

Ermias Diro, Tansy Edwards, Koert Ritmeijer, Helina Fikre, Charles Abongomera, Aderajew Kibret, Clélia Bardonneau, Peninah Soipei, Brian Mutinda, Raymond Omollo and 8 more

Registry-linked trialAbstract read
In one paragraph

Article in PLoS neglected tropical diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02011958 (A Randomized Trial of Ambisome Monotherapy and Combination of Ambisome and Miltefosine for the Treatment of VL in HIV Positive Patients in Ethiopia Followed by Secondary VL Prophylactic Treatment With Pentamidine.), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT02011958 phase3completednot on this map

A Randomized Trial of Ambisome Monotherapy and Combination of Ambisome and Miltefosine for the Treatment of VL in HIV Positive Patients in Ethiopia Followed by Secondary VL Prophylactic Treatment With Pentamidine.

TypeinterventionalSponsorDrugs for Neglected DiseasesRan2014 to 2017Enrolled59ConditionsVisceral LeishmaniasisArmsLiposomal Amphotericin B, Miltefosine
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Trial
  3. Article
  4. Assessment of asymptomaticFrontiers in medicine · 2025
    Article
  5. Article
  6. Immune response to viscerotropicFrontiers in immunology · 2024
    Review
  7. Article
  8. Article
  9. How I Approach Leishmaniasis: Diagnosis and Treatment in the United States.Journal of the Pediatric Infectious Diseases Society · 2022
    Article
  10. Article
  11. Article
  12. Article
  13. Review
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

18 authors.

Ermias DiroLeishmaniasis Research and Treatment Centre, University of Gondar, Gondar, Ethiopia.ORCID 0000-0002-3595-6323
Tansy EdwardsMRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.ORCID 0000-0002-6110-014X
Koert RitmeijerMédecins sans Frontières, Amsterdam, The Netherlands.
Helina FikreLeishmaniasis Research and Treatment Centre, University of Gondar, Gondar, Ethiopia.
Charles AbongomeraAbdurafi Health Centre, Médecins sans Frontières, Ethiopia.
Aderajew KibretAbdurafi Health Centre, Médecins sans Frontières, Ethiopia.
Clélia BardonneauResearch & Development Department, Drugs for Neglected Diseases initiative, Geneva, Switzerland.
Peninah SoipeiDrugs for Neglected Diseases initiative, Nairobi, Kenya.ORCID 0000-0002-1689-8770
Brian MutindaDrugs for Neglected Diseases initiative, Nairobi, Kenya.
Raymond OmolloDrugs for Neglected Diseases initiative, Nairobi, Kenya.
Johan van GriensvenInstitute of Tropical Medicine, Antwerp, Belgium.
Eduard E ZijlstraResearch & Development Department, Drugs for Neglected Diseases initiative, Geneva, Switzerland.
Monique WasunnaDrugs for Neglected Diseases initiative, Nairobi, Kenya.
Fabiana AlvesResearch & Development Department, Drugs for Neglected Diseases initiative, Geneva, Switzerland.
Jorge AlvarResearch & Development Department, Drugs for Neglected Diseases initiative, Geneva, Switzerland.
Asrat HailuDepartment of Microbiology, Immunology, and Parasitology, Addis Ababa University, Addis Ababa, Ethiopia.
Neal AlexanderMRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.
Séverine BlessonResearch & Development Department, Drugs for Neglected Diseases initiative, Geneva, Switzerland.

Funding

Medical Research Council MR/K012126/1Medical Research Council MR/R010161/1
6 · The paper itself

Abstract

backgroundThe long-term treatment outcome of visceral leishmaniasis (VL) patients with HIV co-infection is complicated by a high rate of relapse, especially when the CD4 count is low. Although use of secondary prophylaxis is recommended, it is not routinely practiced and data on its effectiveness and safety are limited.

methodsA prospective cohort study was conducted in Northwest Ethiopia from August 2014 to August 2017 (NCT02011958). HIV-VL patients were followed for up to 12 months. Patients with CD4 cell counts below 200/μL at the end of VL treatment received pentamidine prophylaxis starting one month after parasitological cure, while those with CD4 count ≥200 cells/μL were followed without secondary prophylaxis. Compliance, safety and relapse-free survival, using Kaplan-Meier analysis methods to account for variable time at risk, were summarised. Risk factors for relapse or death were analysed.

resultsFifty-four HIV patients were followed. The probability of relapse-free survival at one year was 50% (95% confidence interval [CI]: 35-63%): 53% (30-71%) in 22 patients with CD4 ≥200 cells/μL without pentamidine prophylaxis and 46% (26-63%) in 29 with CD4 <200 cells/μL who started pentamidine. Three patients with CD4 <200 cells/μL did not start pentamidine. Amongst those with CD4 ≥200 cells/μL, VL relapse was an independent risk factor for subsequent relapse or death (adjusted rate ratio: 5.42, 95% CI: 1.1-25.8). Except for one case of renal failure which was considered possibly related to pentamidine, there were no drug-related safety concerns.

conclusionThe relapse-free survival rate for VL patients with HIV was low. Relapse-free survival of patients with CD4 count <200cells/μL given pentamidine secondary prophylaxis appeared to be comparable to patients with a CD4 count ≥200 cells/μL not given prophylaxis. Patients with relapsed VL are at higher risk for subsequent relapse and should be considered a priority for secondary prophylaxis, irrespective of their CD4 count.

Indexed as

AdultAntiprotozoal AgentsCD4 Lymphocyte CountCohort StudiesCoinfectionEthiopiaFemaleHIV InfectionsHumansLeishmaniasis, VisceralMaleMiddle AgedPentamidinePrognosisProspective StudiesRisk FactorsAntiprotozoal AgentsPentamidine

Identifiers

PMID30789910
PMCPMC6400407

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Registered trials

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.