Evidence map›Paper›PMID 29239893›Full record

Trial reportAIDS (London, England)2018

Switch from tenofovir disoproxil fumarate combination to dolutegravir with rilpivirine improves parameters of bone health.

Grace A McComsey, Sergio Lupo, David Parks, Mónica Coronado Poggio, Joseph De Wet, Lesley P Kahl, Kostas Angelis, Brian Wynne, Kati Vandermeulen, Martin Gartland and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in AIDS (London, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02478632 (An Evaluation of Bone Mineral Density in HIV-1-infected Adult Subjects Switching From a Tenofovir-containing Antiretroviral Therapy Regimen to a Dolutegravir Plus Rilpivirine Regimen), which is not on this map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
3.7field-weighted citation impact, top 6% 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.

NCT02478632 phase3completednot on this map

An Evaluation of Bone Mineral Density in HIV-1-infected Adult Subjects Switching From a Tenofovir-containing Antiretroviral Therapy Regimen to a Dolutegravir Plus Rilpivirine Regimen

TypeinterventionalSponsorViiV HealthcareRan2015 to 2018Enrolled102ConditionsHIV InfectionsArmsSubjects do not receive study medication in this study 202094
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 56 citations in OpenAlex.

  1. Diagnosis, prevention, and treatment of bone fragility in people living with HIV: a position statement from the Swiss Association against Osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019
    Guideline
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Article
  9. Cardiometabolic health in people with HIV: expert consensus review.The Journal of antimicrobial chemotherapy · 2024
    Review
  10. Article
  11. Article
  12. Review
  13. Article
  14. Observational
  15. Osteoporosis and HIV Infection.Calcified tissue international · 2022
    Review
  16. Secondary Osteoporosis and Metabolic Bone Diseases.Journal of clinical medicine · 2022
    Review
  17. Article
  18. Article
  19. Review
  20. 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

13 authors at 7 institutions in 5 countries.

Grace A McComseyUniversity Hospitals Cleveland Medical Center and Case Western Reserve University, Cleveland, Ohio, USA.
Sergio LupoCAICA Institute, Rosario, Argentina.
David ParksCentral West Clinical Research, St. Louis, Missouri, USA.
Mónica Coronado PoggioMedicina Nuclear, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain.
Joseph De WetSpectrum Health, Vancouver, British Columbia, Canada.
Lesley P KahlViiV Healthcare, Brentford.
Kostas AngelisGlaxoSmithKline, Uxbridge, UK.
Brian WynneViiV Healthcare, Collegeville, Pennsylvania, USA.
Kati VandermeulenJanssen, Beerse, Belgium.
Martin GartlandViiV Healthcare, Research Triangle Park, North Carolina.
Michael CupoGlaxoSmithKline, Collegeville, Pennsylvania, USA.
Michael AboudViiV Healthcare, Brentford.
202094 Sub-Study Investigators
ViiV Healthcare (United Kingdom) · GBGlaxoSmithKline (United Kingdom) · GBGlaxoSmithKline (United States) · USHospital Universitario La Paz · ESInstitute of Physics Rosario · ARJanssen (Belgium) · BEUniversity Hospitals of Cleveland · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveBone mineral density (BMD) loss, a risk factor for osteoporosis, has been attributed to HIV infection and antiretroviral therapy (ART), including regimens containing tenofovir disoproxil fumarate.

designStudy 202094 is an open-label, parallel-group, sub-study of the phase III SWORD-1 and SWORD-2 studies (ClinicalTrials.gov identifier, NCT02478632).

methodsHIV-1-infected adults with HIV-1 RNA less than 50 copies/ml who received ART containing tenofovir disoproxil fumarate for at least 6 months were randomized to receive dolutegravir with rilpivirine or continue current ART regimen. Total hip and lumbar spine BMD were measured by dual-energy X-ray absorptiometry (DXA) scans. The primary endpoint was percentage change from baseline in total hip BMD.

resultsDXA scans were evaluable for 81 participants at baseline and Week 48. Percentage increase in total hip BMD was significantly greater in participants who switched to dolutegravir with rilpivirine (1.34%) compared with participants who continued current ART (0.05%; treatment difference, +1.29%; 95% CI 0.27-2.31; P = 0.014). Lumbar spine BMD significantly increased in the dolutegravir with rilpivirine group by 1.46% (95% CI 0.65-2.28) compared with 0.15% (95% CI -0.79 to 1.09) in the current ART group (treatment difference, 1.32; 95% CI 0.07-2.57; P = 0.039). Participants in the dolutegravir with rilpivirine group experienced significantly greater reductions in bone formation and resorption biomarkers compared with the current ART group.

conclusionSwitch to dolutegravir with rilpivirine was associated with significant improvement in BMD and bone turnover markers compared with tenofovir-based three-drug regimens, providing a robust option for preserving bone health while continuing suppressive ART.

Indexed as

Drug SubstitutionAbsorptiometry, PhotonAdultAgedAged, 80 and overAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveBone DensityDolutegravirFemaleHeterocyclic Compounds, 3-RingHIV InfectionsHumansMaleMiddle AgedOsteoporosisAnti-HIV AgentsDolutegravirHeterocyclic Compounds, 3-RingOxazinesPiperazinesPyridonesRilpivirineTenofovir

Identifiers

PMID29239893
PMCPMC5802259
OpenAlexW2772479121

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.