Evidence map›Paper›PMID 27029778›Full record

Trial reportThe Journal of infectious diseases2016

Low Risk of Proximal Tubular Dysfunction Associated With Emtricitabine-Tenofovir Disoproxil Fumarate Preexposure Prophylaxis in Men and Women.

Kenneth Mugwanya, Jared Baeten, Connie Celum, Deborah Donnell, Thomas Nickolas, Nelly Mugo, Andrea Branch, Jordan Tappero, James Kiarie, Allan Ronald and 3 more

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

Trial report in The Journal of infectious diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00557245 (Parallel Comparison of Tenofovir and Emtricitabine/Tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
4.9field-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.

NCT00557245 phase3completednot on this map

Parallel Comparison of Tenofovir and Emtricitabine/Tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples

TypeinterventionalSponsorUniversity of WashingtonRan2008 to 2013Enrolled4,758ConditionsHIV-1 Infections, HIV InfectionsArmsTenofovir Disoproxil Fumarate (TDF), Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Placebo
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  8. Review
  9. Article
  10. Review
  11. Article
  12. Mechanisms of Proteinuria in HIV.Frontiers in medicine · 2021
    Review
  13. Article
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  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Kidney Disease in HIV: Moving beyond HIV-Associated Nephropathy.Journal of the American Society of Nephrology : JASN · 2017
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 10 institutions in 4 countries.

Kenneth MugwanyaDepartment of Epidemiology Department of Global Health Division of Disease Control, School of Public Health, Makerere University, Kampala, Uganda.
Jared BaetenDepartment of Epidemiology Department of Global Health Department of Medicine, University of Washington.
Connie CelumDepartment of Epidemiology Department of Global Health Department of Medicine, University of Washington.
Deborah DonnellDepartment of Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Thomas NickolasDepartment of Medicine, Division of Nephrology.
Nelly MugoDepartment of Global Health Kenya Medical Research Institute.
Andrea BranchDepartment of Medicine, Division of Liver Diseases.
Jordan TapperoDivision of Global Health Protection, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia.
James KiarieDepartment of Obstetrics and Gynecology, University of Nairobi, Kenya.
Allan RonaldDepartment of Medicine, University of Manitoba, Winnipeg, Canada.
Michael YinDepartment of Medicine, Division of Infectious Diseases, Columbia University Medical Center.
Christina WyattDepartment of Medicine, Division of Nephrology, Icahn School of Medicine at Mount Sinai, New York, New York.
Partners PrEP Study Team
University of Washington · USCenter for Digestive and Liver Diseases · USCenters for Disease Control and Prevention · USColumbia University Irving Medical Center · USFred Hutch Cancer Center · USIcahn School of Medicine at Mount Sinai · USKenya Medical Research Institute · KEMakerere University · UGUniversity of Manitoba · CAUniversity of Nairobi · KE

Funding

Optimizing Antiretroviral-Based HIV Prevention for HIV Serodiscordant CouplesR01MH095507 · NIMH · UNIVERSITY OF WASHINGTON · PI BAETEN, JARED · 2011 to 2020
$6.1M
Incidence and Implications of Subclinical Kidney Injury with Tenofovir based PrEPR01DK100272 · NIDDK · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI WYATT, CHRISTINA M · 2014 to 2016
$1.8M
NIDDK NIH HHS R01 DK100272NIMH NIH HHS R01 MH095507
6 · The paper itself

Abstract

objectiveTenofovir disoproxil fumarate (TDF) is associated with proximal tubular dysfunction (tubulopathy) when used in the treatment of human immunodeficiency virus (HIV) infection. We evaluated whether TDF causes tubulopathy when used as HIV preexposure prophylaxis (PrEP) and whether tubulopathy predicts clinically relevant decline (≥25%) in the estimated glomerular filtration rate (eGFR).

methodsA subgroup analysis of the Partners PrEP Study, a randomized, placebo-controlled trial of daily oral TDF, alone or with emtricitabine (FTC), in HIV-uninfected African men and women (Clinicaltrials.gov NCT00557245). Tubulopathy was assessed in concurrently obtained urine and serum samples at the 24-month or last on-treatment visit, predefined as ≥2 of the following: tubular proteinuria, euglycemic glycosuria, increased urinary phosphate, and uric acid excretion.

resultsOf 1549 persons studied (776 receiving FTC-TDF, 773 receiving placebo), 64% were male, and the median age was 37 years. Over a median 24 months of study-drug exposure, the frequency of tubulopathy was 1.7% for FTC-TDF versus 1.3% for placebo (odds ratio, 1.30; 95% confidence interval, .52-3.33; P = .68); Tubulopathy occurred in 2 of 52 persons (3.8%) with versus 3 of 208 (1.4%) without ≥25% eGFR decline (adjusted odds ratio, 1.39; .10-14.0; P > .99).

conclusionsDaily oral FTC-TDF PrEP was not significantly associated with tubulopathy over the course of 24 months, nor did tubulopathy predict clinically relevant eGFR decline.

Indexed as

AdolescentAdultAnti-HIV AgentsChemopreventionFemaleHIV InfectionsHumansMaleMiddle AgedPlacebosPre-Exposure ProphylaxisRenal InsufficiencyTenofovirUrinalysisYoung AdultAnti-HIV AgentsPlacebosTenofovirPrEPproximal tubular dysfunctionTDF nephrotoxicityTDF toxicity

Identifiers

PMID27029778
PMCPMC5021224
OpenAlexW2322121101

What OpenQuestion holds

Textmetadata
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.