Evidence map›Paper›PMID 29714167›Full record

Trial reportAntiviral therapy2018

Virological and immunological responses to raltegravir and dolutegravir in the gut-associated lymphoid tissue of HIV-infected men and women.

Michael D Weber, Elizabeth Andrews, Heather A Prince, Craig Sykes, Elias P Rosen, Camden Bay, Nicholas J Shaheen, Ryan D Madanick, Evan S Dellon, Kristina De Paris and 3 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IV
In one paragraph

Trial report in Antiviral therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02218320 (A Phase IV, Open-Label Study to Compare Virologic and Immunologic Responses to Raltegravir and Dolutegravir in the Gastrointestinal Tract of HIV-Positive Men and Women), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.3field-weighted citation impact, top 45% 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.

NCT02218320 completednot on this map

A Phase IV, Open-Label Study to Compare Virologic and Immunologic Responses to Raltegravir and Dolutegravir in the Gastrointestinal Tract of HIV-Positive Men and Women

TypeobservationalSponsorUniversity of North Carolina, Chapel HillRan2014 to 2015Enrolled20ConditionsHuman Immunodeficiency VirusArmsRaltegravir, Dolutegravir, Colonoscopy with biopsy
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Article
  3. Dolutegravir based therapy showed CD4Scientific reports · 2024
    Article
  4. Article
  5. Article
  6. 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 1 institution in 1 country.

Michael D WeberUniversity of North Carolina Eshelman School of Pharmacy, Chapel Hill, NC, USA.
Elizabeth AndrewsUniversity of North Carolina Eshelman School of Pharmacy, Chapel Hill, NC, USA.
Heather A PrinceUniversity of North Carolina Eshelman School of Pharmacy, Chapel Hill, NC, USA.
Craig SykesUniversity of North Carolina Eshelman School of Pharmacy, Chapel Hill, NC, USA.
Elias P RosenUniversity of North Carolina Eshelman School of Pharmacy, Chapel Hill, NC, USA.
Camden BayDepartment of Biostatistics, University of North Carolina, Chapel Hill, NC, USA.
Nicholas J ShaheenDepartment of Medicine, University of North Carolina, Chapel Hill, NC, USA.
Ryan D MadanickDepartment of Medicine, University of North Carolina, Chapel Hill, NC, USA.
Evan S DellonDepartment of Medicine, University of North Carolina, Chapel Hill, NC, USA.
Kristina De ParisDepartment of Microbiology and Immunology, University of North Carolina, Chapel Hill, NC, USA.
Julie Ae NelsonDepartment of Microbiology and Immunology, University of North Carolina, Chapel Hill, NC, USA.
Cynthia L GayDepartment of Medicine, University of North Carolina, Chapel Hill, NC, USA.
Angela Dm KashubaUniversity of North Carolina Eshelman School of Pharmacy, Chapel Hill, NC, USA.
University of North Carolina at Chapel Hill · US

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
North Carolina Translational & Clinical Sciences Institute (NC TraCS)UL1TR001111 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$43.9M
NCATS NIH HHS UL1 TR001111NIAID NIH HHS P30 AI050410
6 · The paper itself

Abstract

backgroundRaltegravir (RTG) and dolutegravir (DTG) have different pharmacokinetic patterns in the gastrointestinal tract. To determine if this results in pharmacodynamic differences, we compared HIV RNA, HIV DNA and immunological markers in gut-associated lymphoid tissue (GALT) of HIV-infected participants receiving RTG or DTG with tenofovir+emtricitabine (TDF/FTC).

methodsGALT specimens from the terminal ileum, splenic flexure and rectum were obtained by colonoscopy at a single time point in 20 adults treated with RTG (n=10) or DTG (n=10) with HIV RNA <50 copies/ml. Flow cytometry, drug concentrations, and HIV RNA and DNA were analysed in tissue. CD4/8

resultsA total of 15 men and 5 women were enrolled. There was no difference in time since HIV diagnosis for those on RTG (9.5 [4-22] years) and DTG (17 [1-24] years; P=0.6), although time on RTG (5.4 [2.3-6.7] years) was greater than DTG (1.0 [0.1-1.5] years; P<0.001). Concentrations of RTG and DTG in rectal tissue were similar to previous reports: median tissue:plasma ratio was 11.25 for RTG and 0.44 for DTG. RNA:DNA ratios were 1.14 (0.18-5.10) for the RTG group and 0.90 (0.30-18.87) for the DTG group (P=0.95). No differences (P≥0.1) between CD4

conclusionsRTG produced higher tissue exposures than DTG, but no significant differences in GALT HIV RNA, DNA or most immunological markers were observed. ClinicalTrials.gov NCT02218320.

Indexed as

AdultAnti-HIV AgentsCD4 Lymphocyte CountCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesColon, TransverseDNA, ViralDolutegravirEmtricitabineFemaleGene ExpressionHeterocyclic Compounds, 3-RingHIV-1HIV InfectionsHumansIleumAnti-HIV AgentsDNA, ViralDolutegravirEmtricitabineHeterocyclic Compounds, 3-RingOxazinesPiperazinesPyridonesRaltegravir PotassiumReceptors, Antigen, T-Cell, gamma-deltaRNA, ViralTenofovir

Identifiers

PMID29714167
PMCPMC7376574
OpenAlexW2801839030

What OpenQuestion holds

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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.