Evidence map›Paper›PMID 24625508›Full record

Trial reportPloS one2014

High level of viral suppression and low switch rate to second-line antiretroviral therapy among HIV-infected adult patients followed over five years: retrospective analysis of the DART trial.

Cissy Kityo, Diana M Gibb, Charles F Gilks, Ruth L Goodall, Ivan Mambule, Pontiano Kaleebu, Deenan Pillay, Ronnie Kasirye, Peter Mugyenyi, A Sarah Walker and 2 more

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 40% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. 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

12 authors at 6 institutions in 3 countries.

Cissy KityoJoint Clinical Research Centre, Kampala, Uganda.
Diana M GibbMRC Clinical Trials Unit at UCL, London, United Kingdom.
Charles F GilksSchool of Population Health, University of Queensland, Australia.
Ruth L GoodallMRC Clinical Trials Unit at UCL, London, United Kingdom.
Ivan MambuleInfectious Diseases Institute, Mulago, Uganda.
Pontiano KaleebuMRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda.
Deenan PillayUniversity College London, London, United Kingdom.
Ronnie KasiryeMRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda.
Peter MugyenyiJoint Clinical Research Centre, Kampala, Uganda.
A Sarah WalkerMRC Clinical Trials Unit at UCL, London, United Kingdom.
David T DunnMRC Clinical Trials Unit at UCL, London, United Kingdom.
DART Trial Team
University College London · GBJoint Clinical Research Centre · UGUganda Virus Research Institute · UGInfectious Diseases Institute · UGMRC Clinical Trials Unit at UCL · GBUniversity of Queensland · AU

Funding

Medical Research Council G0600344Medical Research Council MC_U950080931Medical Research Council MC_U950080938Wellcome Trust 097410
6 · The paper itself

Abstract

unlabelledIn contrast to resource-rich countries, most HIV-infected patients in resource-limited countries receive treatment without virological monitoring. There are few long-term data, in this setting, on rates of viral suppression or switch to second-line antiretroviral therapy. The DART trial compared clinically driven monitoring (CDM) versus routine laboratory (CD4/haematology/biochemistry) and clinical monitoring (LCM) in HIV-infected adults initiating therapy. There was no virological monitoring in either study group during follow-up, but viral load was measured in Ugandan participants at trial closure. Two thousand three hundred and seventeen (2317) participants from this country initiated antiretroviral therapy with zidovudine/lamivudine plus tenofovir (n = 1717), abacavir (n = 300), or nevirapine (n = 300). Of 1896 (81.8%) participants who were alive and in follow-up at trial closure (median 5.1 years after therapy initiation), 1507 (79.5%) were on first-line and 389 (20.5%) on second-line antiretroviral therapy. The overall switch rate after the first year was 5.6 per 100 person-years; the rate was substantially higher in participants with low baseline CD4 counts (<50 cells/mm3). Among 1207 (80.1%) first-line participants with viral load measured, HIV RNA was <400 copies/ml in 963 (79.8%), 400-999 copies/ml in 37 (3.1%), 1,000-9,999 copies/ml in 110 (9.1%), and ≥10,000 copies/ml in 97 (8.0%). The proportion with HIV RNA <400 copies/ml was slightly lower (difference 7.1%, 95% CI 2.5 to 11.5%) in CDM (76.3%) than in LCM (83.4%). Among 252 (64.8%) second-line participants with viral load measured (median 2.3 years after switch), HIV RNA was <400 copies/ml in 226 (89.7%), with no difference between monitoring strategies. Low switch rates and high, sustained levels of viral suppression are achievable without viral load or CD4 count monitoring in the context of high-quality clinical care.

trial registrationISRCTN13968779.

Indexed as

AbacavirAdultAnti-HIV AgentsCD4 Lymphocyte CountCD4-Positive T-LymphocytesCross-Sectional StudiesDideoxynucleosidesDrug CombinationsFemaleHIV InfectionsHumansLamivudineMaleMiddle AgedNevirapineProbabilityAbacavirAnti-HIV AgentsDideoxynucleosidesDrug CombinationsLamivudinelamivudine, zidovudine drug combinationNevirapineRNA, ViralTenofovirZidovudine

Identifiers

PMID24625508
PMCPMC3953124
OpenAlexW2000691428

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.