Evidence map›Paper›PMID 37232940›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023

Single High Dose of Liposomal Amphotericin B in Human Immunodeficiency Virus/AIDS-Related Disseminated Histoplasmosis: A Randomized Trial.

Alessandro C Pasqualotto, Daiane Dalla Lana, Cassia S M Godoy, Terezinha do Menino Jesus Silva Leitão, Monica B Bay, Lisandra Serra Damasceno, Renata B A Soares, Roger Kist, Larissa R Silva, Denusa Wiltgen and 13 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06926569 (Single High-dose of Liposomal Amphotericin B in Combination With B/F/TAF for HIV/AIDS-associated Talaromycosis), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
6.6field-weighted citation impact, top 2% 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.

NCT06926569 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

Single High-dose of Liposomal Amphotericin B in Combination With B/F/TAF for HIV/AIDS-associated Talaromycosis

TypeinterventionalSponsorShanghai Public Health Clinical CenterRan2025 to 2026Enrolled116ConditionsHIV/AIDS-associated TalaromycosisArmsAmphotericin B, AmBisome
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 34 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Disseminated histoplasmosis with bone marrow infiltration in a newly diagnosed HIV patient.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2025
    Article
  14. Histoplasmosis.Infectious disease clinics of North America · 2025
    Review
  15. Review
  16. Observational
  17. Histoplasmosis in Solid Organ Transplantation.Journal of fungi (Basel, Switzerland) · 2024
    Review
  18. Review
  19. Predictors of mortality in hospitalized patients with disseminated histoplasmosis.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases
    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

23 authors at 14 institutions in 6 countries.

Alessandro C PasqualottoDepartment of Clinical Medicine and Post-Graduation Program in Pathology, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.ORCID 0000-0002-6782-5395
Daiane Dalla LanaDepartment of Clinical Medicine and Post-Graduation Program in Pathology, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.
Cassia S M GodoyInfectious Diseases Service, Hospital de Doenças Tropicais, Goiânia, Brazil.
Terezinha do Menino Jesus Silva LeitãoInfectious Diseases Service, Hospital São José de Doenças Infecciosas, Fortaleza, Brazil.
Monica B BayDepartment of Infectious Diseases, Federal University of Rio Grande do Norte, Natal, Brazil.
Lisandra Serra DamascenoInfectious Diseases Service, Hospital São José de Doenças Infecciosas, Fortaleza, Brazil.
Renata B A SoaresInfectious Diseases Service, Hospital de Doenças Tropicais, Goiânia, Brazil.
Roger KistInfectious Diseases and Internal Medicine Services, Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Brazil.
Larissa R SilvaDepartment of Clinical Medicine and Post-Graduation Program in Pathology, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.
Denusa WiltgenDepartment of Clinical Medicine and Post-Graduation Program in Pathology, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.
Marineide MeloInfectious Diseases Service, Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil.
Taiguara F GuimarãesInfectious Diseases Service, Hospital de Doenças Tropicais, Goiânia, Brazil.
Marilia R GuimarãesDepartment of Nephrology, Universidade de São Paulo, São Paulo, Brazil.
Hareton T VechiDepartment of Infectious Diseases, Federal University of Rio Grande do Norte, Natal, Brazil.
Jacó R L de MesquitaInfectious Diseases Service, Hospital São José de Doenças Infecciosas, Fortaleza, Brazil.
Gloria Regina de G MonteiroDepartment of Infectious Diseases, Federal University of Rio Grande do Norte, Natal, Brazil.
Antoine AdenisCentre d'Investigation Clinique Antilles Guyane Inserm CIC1424, Centre Hospitalier de Cayenne, Cayenne, France.
Nathan C BahrDivision of Infectious Diseases, Department of Medicine, University of Kansas Medical Center, Kansas City, Kansas, USA.
Andrej SpecDivision of Infectious Disease, Washington University in St. Louis School of Medicine, St. Louis, Missouri, USA.
David R BoulwareDivision of Infectious Diseases and International Medicine, Department of Medicine, University of Minnesota, Minnesota, USA.
Dennis IsraelskiInternational Medical Affairs, Global Patient Solutions, Gilead Sciences, San Francisco, California, USA.
Tom ChillerMycotic Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Diego R FalciInfectious Diseases Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Universidade Federal de Ciências da Saúde de Porto Alegre · BRUniversidade Federal do Rio Grande do Norte · BRPontifícia Universidade Católica de Goiás · BRUniversidade Federal do Ceará · BRCenters for Disease Control and Prevention · USGilead Sciences (United States) · USHospital Nossa Senhora da Conceição · BRInserm · FRSanta Casa de Misericórdia de Marília · BRServices Hospital · PKUniversidade de São Paulo · BRUniversity of Kansas Medical Center · USUniversity of Minnesota · USWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHistoplasmosis is a major AIDS-defining illness in Latin America. Liposomal amphotericin B (L-AmB) is the drug of choice for treatment, but access is restricted due to the high drug and hospitalization costs of the conventional long regimens.

methodsProspective randomized multicenter open-label trial of 1- or 2-dose induction therapy with L-AmB versus control for disseminated histoplasmosis in AIDS, followed by oral itraconazole therapy. We randomized subjects to: (i) single dose 10 mg/kg of L-AmB; (ii) 10 mg/kg of L-AmB on D1, and 5 mg/kg of L-AmB on D3; (iii) 3 mg/kg of L-AmB daily for 2 weeks (control). The primary outcome was clinical response (resolution of fever and signs/symptoms attributable to histoplasmosis) at day 14.

resultsA total of 118 subjects were randomized, and median CD4+ counts, and clinical presentations were similar between arms. Infusion-related toxicity, kidney toxicity at multiple time-points, and frequency of anemia, hypokalemia, hypomagnesemia, and liver toxicity were similar. Day 14 clinical response was 84% for single-dose L-AmB, 69% 2-dose L-AmB, and 74% for control arm (P = .69). Overall survival on D14 was 89.0% (34/38) for single-dose L-AmB, 78.0% (29/37) for 2-dose L-AmB, and 92.1% (35/38) for control arm (P = .82).

conclusionsOne day induction therapy with 10 mg/kg of L-AmB in AIDS-related histoplasmosis was safe. Although clinical response may be non-inferior to standard L-AmB therapy, a confirmatory phase III clinical trial is needed. A single induction dose would markedly reduce drug-acquisition costs (>4-fold) and markedly shorten and simplify treatment, which are key points in terms of increased access.

Indexed as

Acquired Immunodeficiency SyndromeDrug-Related Side Effects and Adverse ReactionsHistoplasmosisAmphotericin BAntifungal AgentsHIVHumansProspective StudiesAmphotericin BAntifungal Agentsliposomal amphotericin BAIDSdisseminated histoplasmosisHIVliposomal amphotericin Btreatment

Identifiers

PMID37232940
PMCPMC10573726
OpenAlexW4378349414

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.