Evidence map›Paper›PMID 26009024›Full record

Trial reportContemporary clinical trials2015

Safety of discontinuing cotrimoxazole prophylaxis among HIV infected adults on anti-retroviral therapy in Uganda (COSTOP trial): Design.

Zacchaeus Anywaine, Andrew Abaasa, Jonathan Levin, Ronnie Kasirye, Anatoli Kamali, Heiner Grosskurth, Paula Munderi, Andrew Nunn

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.6field-weighted citation impact, top 19% 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

12 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. 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

8 authors at 4 institutions in 3 countries.

Zacchaeus AnywaineMRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda. Electronic address: Zacchaeus.Anywaine@mrcuganda.org.
Andrew AbaasaMRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda. Electronic address: Andrew.Abaasa@mrcuganda.org.
Jonathan LevinMRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda; School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: Jonathan.Levin@mrcuganda.org.
Ronnie KasiryeMRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda. Electronic address: Ronnie.Kasirye@mrcuganda.org.
Anatoli KamaliMRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda. Electronic address: Anatoli.Kamali@mrcuganda.org.
Heiner GrosskurthMRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda; London School of Hygiene and Tropical Medicine, London, UK. Electronic address: Heiner.Grosskurth@lshtm.ac.uk.
Paula MunderiMRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda. Electronic address: Paula.Munderi@mrcuganda.org.
Andrew NunnMRC Clinical Trials Unit at University College London, UK. Electronic address: a.nunn@ucl.ac.uk.
Uganda Virus Research Institute · UGLondon School of Hygiene & Tropical Medicine · GBMRC Clinical Trials Unit at UCL · GBUniversity of the Witwatersrand · ZA

Funding

Medical Research Council G0902150Medical Research Council MC_EX_G0902150Medical Research Council MC_EX_UU_G0902150Medical Research Council MR/K012126/1
6 · The paper itself

Abstract

introductionCotrimoxazole (CTX) prophylaxis is recommended by the World Health Organisation for HIV infected persons. However, once HIV infected patients have commenced ART in resource limited settings, the benefits of continued CTX prophylaxis are not known. The few studies that investigated the safety of discontinuing CTX prophylaxis in these settings had limitations due to their design. MATERIALS AND

methodsCOSTOP is a randomised double blind placebo controlled non-inferiority trial among HIV infected Ugandan adults stabilised on anti-retroviral treatment (ART). Participants with CD4 count of 250 or more cells/mm(3) are randomised to two arms: the intervention arm in which CTX is discontinued and the control arm in which CTX prophylaxis is continued. The study aims to assess whether the intervention regimen is not inferior, with respect to the incidence of pre-defined CTX-preventable events, to the control regimen and superior with respect to the incidence of haematological adverse events. DISCUSSION: Studies that have previously evaluated the safety of discontinuing CTX prophylaxis among HIV infected adults in resource limited settings have provided moderate to low quality evidence owing in part to methodological limitations. COSTOP is designed and conducted with sufficient rigour to answer this question. The results of the trial will assist in guiding policy recommendations.

conclusionThis paper describes the design and methodological considerations important for the conduct of CTX cessation studies.

Indexed as

Research DesignAIDS-Related Opportunistic InfectionsAnti-Retroviral AgentsCD4 Lymphocyte CountDouble-Blind MethodDrug Administration ScheduleFemaleHIV InfectionsHumansIncidenceMaleTrimethoprim, Sulfamethoxazole Drug CombinationUgandaAnti-Retroviral AgentsTrimethoprim, Sulfamethoxazole Drug CombinationAntiretroviral treatmentCotrimoxazole cessation study designCotrimoxazole prophylaxisHIV infectionStopping cotrimoxazoleUganda

Identifiers

PMID26009024
PMCPMC4542218
OpenAlexW305710879

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.