Evidence map›Paper›PMID 21849285›Full record

Trial reportThe Journal of infectious diseases2011

A randomized trial of punctuated antiretroviral therapy in Ugandan HIV-seropositive adults with pulmonary tuberculosis and CD4⁺ T-cell counts of ≥ 350 cells/μL.

M W Nanteza, H Mayanja-Kizza, E Charlebois, P Srikantiah, R Lin, E Mupere, P Mugyenyi, W H Boom, R D Mugerwa, D V Havlir and 1 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.8field-weighted citation impact, top 29% 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

9 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Age, sex, and nutritional status modify the CD4+ T-cell recovery rate in HIV-tuberculosis co-infected patients on combination antiretroviral therapy.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2015
    Article
  6. Relapse more common than reinfection in recurrent tuberculosis 1-2 years post treatment in urban Uganda.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2013
    Article
  7. Article
  8. Bacteremic disseminated tuberculosis in sub-saharan Africa: a prospective cohort study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2012
    Article
  9. Optimal treatment of Codisease due to HIV and tuberculosis.The Journal of infectious diseases · 2011
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 2 countries.

M W NantezaUganda-Case Western Reserve University Research Collaboration, Makerere University, Kampala, Uganda.
H Mayanja-Kizza
E Charlebois
P Srikantiah
R Lin
E Mupere
P Mugyenyi
W H Boom
R D Mugerwa
D V Havlir
C C Whalen
University of California, San Francisco · USMakerere University · UGCase Western Reserve University · USJoint Clinical Research Centre · UGUniversity of Georgia · US

Funding

Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI STEVEN Grant DEEKS · 1988 to 2026
$93.6M
TRAINING IN HIV-RELATED MALIGNANCIESD43TW000011 · FIC · CASE WESTERN RESERVE UNIVERSITY · PI WHALEN, CHRISTOPHER C. · 1988 to 2012
$10.9M
HIV/TB in Uganda: Punctuated Antiretroviral TherapyR01AI051219 · NIAID · UNIVERSITY OF GEORGIA · PI WHALEN, CHRISTOPHER C. · 2003 to 2007
$6.1M
Tuberculosis Prevention Research Unit /TBRU/-266095383N01AI095383 · NIAID · CASE WESTERN RESERVE UNIVERSITY · 2000 to 2005
$5.6M
FIC NIH HHS D43 TW000011NIAID NIH HHS N01 AI070022NIAID NIH HHS N01 AI095383NIAID NIH HHS P30 AI027763NIAID NIH HHS R01 AI051219
6 · The paper itself

Abstract

backgroundOptimal treatment of human immunodeficiency virus (HIV)-associated tuberculosis in patients with high CD4⁺ T-cell counts is unknown. Suppression of viral replication during therapy for tuberculosis may block effects of immune activation on T cells and slow HIV disease progression.

methodsWe conducted a randomized trial in 214 HIV-infected patients with active tuberculosis and CD4⁺ T-cell counts of ≥ 350 cells/μL to determine whether 6 months of antiretroviral therapy given during tuberculosis treatment would improve clinical outcomes. Subjects were randomized to receive 6 months of abacavir-lamivudine-zidovudine concurrent with tuberculosis therapy or delayed antiretroviral therapy. Endpoints were CD4⁺ T-cell counts of < 250 cells/μL, AIDS, or death.

resultsIntervention and comparison arms had similar median CD4⁺ counts (517 and 534 cells/μL, respectively) and HIV RNA levels (4.6 and 4.7 log₁₀ copies/μL, respectively). Viral suppression was achieved in 86% of patients allocated to intervention. Seventeen subjects (15.6%) in the intervention arm developed study outcome compared to 25 subjects (22.8%) in the comparison arm (P = .17). Grade 3 or 4 adverse events were less frequent in the intervention arm. By 2 months, 90% of subjects in both arms were culture-negative for tuberculosis.

conclusionsShort-term antiretroviral therapy during tuberculosis treatment in patients with CD4⁺T-cell counts of >350 cells/μL was safe and associated with clinical benefits.

Indexed as

AbacavirAdolescentAdultAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveAntitubercular AgentsCD4 Lymphocyte CountCD4-Positive T-LymphocytesDideoxynucleosidesFemaleHIV InfectionsHumansLamivudineMaleMiddle AgedSurvival AnalysisAbacavirAnti-HIV AgentsAntitubercular AgentsDideoxynucleosidesLamivudineZidovudine

Identifiers

PMID21849285
PMCPMC3156928
OpenAlexW2110157030

What OpenQuestion holds

Textmetadata
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.