Evidence map›Paper›PMID 24829212›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2014

Renal function of participants in the Bangkok tenofovir study--Thailand, 2005-2012.

Michael Martin, Suphak Vanichseni, Pravan Suntharasamai, Udomsak Sangkum, Philip A Mock, Roman J Gvetadze, Marcel E Curlin, Manoj Leethochawalit, Sithisat Chiamwongpaet, Thitima Cherdtrakulkiat and 8 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00119106 (Study of the Safety and Efficacy of Daily Tenofovir to Prevent HIV Infection Among Injection Drug Users in Bangkok, Thailand), which is not on this map. Cited by 31 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 3 pooled it
4.7field-weighted citation impact, top 5% 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.

NCT00119106 phase2 / phase3completednot on this map

Study of the Safety and Efficacy of Daily Tenofovir to Prevent HIV Infection Among Injection Drug Users in Bangkok, Thailand

TypeinterventionalSponsorCenters for Disease Control and PreventionRan2005 to 2014Enrolled2,413ConditionsHIV InfectionsArmsTenofovir disoproxil, Placebo
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 55 citations in OpenAlex.

  1. Pooled it
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  8. Symptoms, Side Effects and Adherence in the iPrEx Open-Label Extension.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016
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  10. Review
  11. Antimicrobial agents and chemotherapy · 2020
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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

18 authors at 3 institutions in 2 countries.

Michael MartinThailand Ministry of Public Health-US Centers for Disease Control and Prevention Collaboration, Nonthaburi Centers for Disease Control and Prevention, Atlanta, Georgia.
Suphak VanichseniBangkok Tenofovir Study Group.
Pravan SuntharasamaiBangkok Tenofovir Study Group.
Udomsak SangkumBangkok Tenofovir Study Group.
Philip A MockThailand Ministry of Public Health-US Centers for Disease Control and Prevention Collaboration, Nonthaburi.
Roman J GvetadzeCenters for Disease Control and Prevention, Atlanta, Georgia.
Marcel E CurlinThailand Ministry of Public Health-US Centers for Disease Control and Prevention Collaboration, Nonthaburi Centers for Disease Control and Prevention, Atlanta, Georgia.
Manoj LeethochawalitBangkok Metropolitan Administration.
Sithisat ChiamwongpaetBangkok Metropolitan Administration.
Thitima CherdtrakulkiatThailand Ministry of Public Health-US Centers for Disease Control and Prevention Collaboration, Nonthaburi.
Rapeepan AnekvorapongBangkok Metropolitan Administration.
Wanna LeelawiwatThailand Ministry of Public Health-US Centers for Disease Control and Prevention Collaboration, Nonthaburi.
Nartlada ChantharojwongThailand Ministry of Public Health-US Centers for Disease Control and Prevention Collaboration, Nonthaburi.
Janet M McNichollCenters for Disease Control and Prevention, Atlanta, Georgia.
Lynn A PaxtonCenters for Disease Control and Prevention, Atlanta, Georgia.
Somyot KittimunkongThailand Ministry of Public Health, Nonthaburi.
Kachit ChoopanyaBangkok Tenofovir Study Group.
Bangkok Tenofovir Study Group
Ministry of Public Health · THCenters for Disease Control and Prevention · USBangkok Metropolitan Administration · TH

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

backgroundTenofovir disoproxil fumarate (tenofovir) has been associated with renal dysfunction in people infected with human immunodeficiency virus (HIV) receiving combination antiretroviral therapy. We reviewed data from an HIV preexposure prophylaxis trial to determine if tenofovir use was associated with changes in renal function in an HIV-uninfected population.

methodsDuring the trial, 2413 HIV-uninfected people who inject drugs were randomized to receive tenofovir or placebo. We assessed the renal function of trial participants with the Cockcroft-Gault, Modification of Diet in Renal Disease (MDRD), and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations using t tests for cross-sectional analysis and linear regression for longitudinal analysis.

resultsCreatinine clearance and glomerular filtration rate (GFR) results were lower at 24, 36, 48, and 60 months in the tenofovir group compared with the placebo group. Results declined more in the tenofovir group than in the placebo group during follow-up using the Cockcroft-Gault (P < .001) and CKD-EPI (P = .007) equations, but not MDRD (P = .12). Creatinine clearance measured when study drug was stopped was lower in the tenofovir group than the placebo group (P < .001), but the difference resolved when tested a median of 20 months later (P = .12).

conclusionsWe found small but significant decreases in cross-sectional measures of creatinine clearance and GFR in the tenofovir group compared with the placebo group and modest differences in downward trends in longitudinal analysis using the Cockcroft-Gault and CKD-EPI equations. These results suggest that with baseline assessments of renal function and routine monitoring of creatinine clearance during follow-up, tenofovir can be used safely for HIV preexposure prophylaxis. Clinical Trials Registration. NCT00119106.

Indexed as

Pre-Exposure ProphylaxisAdultAnti-HIV AgentsCreatinineCross-Sectional StudiesFemaleGlomerular Filtration RateHIV InfectionsHumansKidneyKidney Function TestsLinear ModelsMaleMiddle AgedReverse Transcriptase InhibitorsTenofovirAnti-HIV AgentsCreatinineReverse Transcriptase InhibitorsTenofovircreatinine clearanceglomerular filtration ratetenofovir disoproxil fumarate

Identifiers

PMID24829212
PMCPMC11310895
OpenAlexW2048943480

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.