Evidence map›Paper›PMID 29590335›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2018

First-line Raltegravir/Emtricitabine/Tenofovir Combination in Human Immunodeficiency Virus Type 2 (HIV-2) Infection: A Phase 2, Noncomparative Trial (ANRS 159 HIV-2).

Sophie Matheron, Diane Descamps, Sebastien Gallien, Amel Besseghir, Pierre Sellier, Laurent Blum, Emmanuel Mortier, Charlotte Charpentier, Roland Tubiana, Florence Damond and 6 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.6field-weighted citation impact, top 10% 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

11 citing papers in PubMed, 28 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. HIV-2: still off the radar for India's 90-90-90 targets.The Indian journal of medical research · 2021
    Article
  6. Long-term Experience and Outcomes of Programmatic Antiretroviral Therapy for Human Immunodeficiency Virus Type 2 Infection in Senegal, West Africa.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Observational
  7. HIV-2 Drug Resistance Genotyping from Dried Blood Spots.Journal of clinical microbiology · 2020
    Article
  8. Article
  9. Article
  10. Article
  11. Antimicrobial agents and chemotherapy · 2018
    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

16 authors at 7 institutions in 1 country.

Sophie MatheronHopital Bichat-Claude Bernard, Assistance Publique-Hôpitaux de Paris (AP-HP).
Diane DescampsHopital Bichat-Claude Bernard, Assistance Publique-Hôpitaux de Paris (AP-HP).
Sebastien GallienHopital Saint Louis, AP-HP, Paris.
Amel BesseghirINSERM, Bordeaux Population Health Research Center, UMR 1219, Université Bordeaux, Institut de santé publique, d'épidémiologie et de développement, Centre Hospitalier Universitaire Bordeaux.
Pierre SellierHopital Lariboisière, AP-HP, Paris.
Laurent BlumCentre Hospitalier René Dubos, Pontoise.
Emmanuel MortierHôpital Louis Mourier, AP-HP, Colombes.
Charlotte CharpentierHopital Bichat-Claude Bernard, Assistance Publique-Hôpitaux de Paris (AP-HP).
Roland TubianaHopital Pitié-Salpetriere, AP-HP, Université Paris 6, INSERM, Institut Pierre-Louis Epidémiologie et Santé Publique, UMR en Santé 1136, Paris, France.
Florence DamondHopital Bichat-Claude Bernard, Assistance Publique-Hôpitaux de Paris (AP-HP).
Gilles PeytavinHopital Bichat-Claude Bernard, Assistance Publique-Hôpitaux de Paris (AP-HP).
Diane PonscarmeHopital Saint Louis, AP-HP, Paris.
Fideline CollinINSERM, Bordeaux Population Health Research Center, UMR 1219, Université Bordeaux, Institut de santé publique, d'épidémiologie et de développement, Centre Hospitalier Universitaire Bordeaux.
Francoise Brun-VezinetUniversité Paris Diderot, Sorbonne Paris Cité.
Genevieve CheneINSERM, Bordeaux Population Health Research Center, UMR 1219, Université Bordeaux, Institut de santé publique, d'épidémiologie et de développement, Centre Hospitalier Universitaire Bordeaux.
France REcherche Nord&Sud Sida-Hiv Hépatites (ANRS) 159 HIV-2 Trial Study Group
Inserm · FRUniversité de Bordeaux · FRAssistance Publique – Hôpitaux de Paris · FRCentre Hospitalier René-Dubos · FRDélégation Paris 7 · FRHôpital Louis-Mourier · FRUniversité Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: New options for first-line treatment of human immunodeficiency virus type 2 (HIV-2) infection are needed. We evaluated an integrase inhibitor (raltegravir)-containing regimen. Methods: Antiretroviral therapy (ART)-naive adults with symptomatic infection by HIV-2 only, CD4 count <500 cells/μL or CD4 decrease >50 cells/μL/year over the past 3 years, or a confirmed plasma HIV-2 RNA (pVL) load ≥100 copies/mL were eligible for this noncomparative trial. The composite primary endpoint was survival at 48 weeks without any of the following: CD4 gain from baseline <100 cells/μL, confirmed pVL ≥40 copies/mL from week 24, raltegravir permanent discontinuation, or incident B or C event. HIV-2 ultrasensitive pVL (uspVL) and total DNA were assessed using in-house polymerase chain reaction (PCR) assays. Results: Baseline median CD4 count of 30 enrolled individuals (67% women) was 436 cells/µL (interquartile range [IQR], 314-507 cells/µL); pVL was ≥40 copies/mL in 67% of them, uspVL was ≥5 copies/mL in 92%, and total DNA was >6 copies by PCR in 32%. At week 48, the composite endpoint of success was reached in 40% [95% confidence interval, 22.7%-59.4%]. Failure was mainly (50%) due to CD4 gain <100 cells/µL; uspVL was <5 copies/mL in 87% and total DNA >6 copies by PCR in 12% of participants. Median CD4 gain was 87 cells/µL (IQR, 38-213 cells/µL; n = 28). No serious adverse reactions were reported. Conclusions: Raltegravir-containing ART is a safe option for first-line treatment of HIV-2 infection, yielding a comparable success rate to protease inhibitors. Clinical Trials Registration: NCT 01605890.

Indexed as

AdultAgedAnti-HIV AgentsCD4 Lymphocyte CountCohort StudiesDrug Therapy, CombinationEmtricitabineFemaleHIV-2HIV InfectionsHumansIntegrase InhibitorsMaleMiddle AgedRaltegravir PotassiumRNA, ViralAnti-HIV AgentsEmtricitabineIntegrase InhibitorsRaltegravir PotassiumRNA, ViralTenofovir

Identifiers

PMID29590335
PMCPMC6160602
OpenAlexW2790839955

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.