Evidence map›Paper›PMID 29415175›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2018

Metabolic Effects of Preexposure Prophylaxis With Coformulated Tenofovir Disoproxil Fumarate and Emtricitabine.

David V Glidden, Kathleen Mulligan, Vanessa McMahan, Peter L Anderson, Juan Guanira, Suwat Chariyalertsak, Susan P Buchbinder, Linda-Gail Bekker, Mauro Schechter, Beatriz Grinsztejn and 1 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00458393 (Chemoprophylaxis for HIV Prevention in Men), which is not on this map. Cited by 34 papers.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed
4.6field-weighted citation impact, top 4% 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.

NCT00458393 phase3completednot on this map

Chemoprophylaxis for HIV Prevention in Men

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2007 to 2014Enrolled2,499ConditionsHIV InfectionsArmsdaily TDF/FTC, Placebo
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 72 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Efavirenz Pharmacogenetics and Weight Gain Following Switch to Integrase Inhibitor-Containing Regimens.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Trial
  4. Switching to Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Virologically Suppressed Adults With Human Immunodeficiency Virus.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Trial
  5. Trial
  6. Trial
  7. Article
  8. Review
  9. Review
  10. Article
  11. Lipodystrophy in HIV: Evolving Challenges and Unresolved Questions.International journal of molecular sciences · 2025
    Review
  12. Article
  13. [Research progress of antiviral treatment for patients with chronic hepatitis B combined with metabolic fatty liver disease].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2024
    Review
  14. Weight Gain and Antiretroviral Therapy.Infectious disease clinics of North America · 2024
    Review
  15. Review
  16. Article
  17. Article
  18. [Research progress on the effect of tenofovir disoproxil fumarate on blood lipid profile].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2023
    Review
  19. Article
  20. 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

11 authors at 8 institutions in 5 countries.

David V GliddenUniversity of California, San Francisco.
Kathleen MulliganUniversity of California, San Francisco.
Vanessa McMahanUniversity of Washington, Seattle.
Peter L AndersonUniversity of Colorado, Denver, Aurora.
Juan GuaniraInvestigaciones Médicas en Salud, Lima, Peru.
Suwat ChariyalertsakResearch Institute for Health Sciences, Chiang Mai University, Thailand.
Susan P BuchbinderUniversity of California, San Francisco.
Linda-Gail BekkerUniversity of California, San Francisco.
Mauro SchechterProjeto Praça Onze, Hospital Escola São Francisco de Assis and Universidade Federal do Rio de Janeiro.
Beatriz GrinsztejnEvandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro, Brazil.
Robert M GrantGladstone Institute of Virology, California.
University of California, San Francisco · USChiang Mai University · THEsSALUD · PEGladstone Institutes · USInstituto Evandro Chagas · BRUniversidade Federal do Rio de Janeiro · BRUniversity of Colorado Denver · USUniversity of Washington · US

Funding

LOC: HIV Prevention Trials NetworkUM1AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI Sinead Delany-Moretlwe, RAPHAEL J LANDOVITZ · 2011 to 2026
$779.5M
Engaging University of California Stakeholders for Biorespository ResearchUL1TR000004 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANDIS, JENNIFER RUBIN · 2012 to 2015
$78.0M
HIV Prevention trials Network (HPTN) Coordinating and Operations CenterU01AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI VERMUND, STEN H. · 2006 to 2010
$72.7M
Chemoprophylaxis for HIV Prevention in Men SupplementU01AI064002 · NIAID · J. DAVID GLADSTONE INSTITUTES · PI GRANT, ROBERT M. · 2005 to 2011
$41.3M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit (FioTrials)UM1AI069476 · NIAID · FUNDACAO OSWALDO CRUZ · PI BEATRIZ GRINSZTEJN · 2012 to 2026
$26.3M
San Francisco Vaccine and Prevention UnitU01AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI BUCHBINDER, SUSAN · 2007 to 2011
$7.3M
Chemoprophylaxis and HIV Host InteractionsR01AI118575 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANT, ROBERT M. · 2015 to 2019
$2.9M
PrEP and ART adherence monitoring using dried blood spotsU01AI106499 · NIAID · UNIVERSITY OF COLORADO DENVER · PI ANDERSON, PETER L. · 2013 to 2016
$2.9M
Comparison of Pharmacologic Markers of Exposure to HIV Pre-Exposure ProphylaxisR03AI122908 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GLIDDEN, DAVID V. · 2016 to 2017
$159k
Chemoprophylaxis for HIV Prevention: Analysis of Bone and Metabolic EffectsR03AI120819 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GLIDDEN, DAVID V. · 2015 to 2016
$158k
NCATS NIH HHS UL1 TR000004NIAID NIH HHS R01 AI118575NIAID NIH HHS R03 AI120819NIAID NIH HHS R03 AI122908NIAID NIH HHS U01 AI064002NIAID NIH HHS U01 AI068619NIAID NIH HHS U01 AI069496NIAID NIH HHS U01 AI106499NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1 AI069476NIAID NIH HHS UM1 AI069496
6 · The paper itself

Abstract

Background: Antiretroviral drugs have been associated with changes in lipids, fat mass and dat distribution. Tenofovir disoproxil fumarate (TDF) has been shown to have a more favorable metabolic profile than other drugs in its class. However, the metabolic effects of TDF in preexposure prophylaxis (PrEP) are unknown. Methods: We evaluated the effects of TDF/emtricitabine (FTC) on lipids and body composition in a blinded, placebo-controlled PrEP trial. Participants enrolled in a metabolic subcohort (N = 251, TDF/FTC; N = 247, placebo) consented to fasting lipid panels, dual-energy X-ray absorptiometry scans for body composition, and pharmacologic testing of drug metabolites at baseline and every 24 weeks thereafter. Results: Lean body mass was stable and unaffected by TDF/FTC. Body weight increased in both groups but was lower on TDF/FTC through week 72. This difference was explained by lower fat accumulation on TDF/FTC. The net median percent difference (standard error, P value) for TDF/FTC vs placebo at week 24 was -0.8% (0.4%, P = .02), +0.3% (0.4%, P = .46), and -3.8% (1.4%, P = .009) for total, lean, and fat mass, respectively. There was no apparent differential regional fat accumulation on TDF/FTC. Decreases in cholesterol, but not triglycerides, were seen in TDF/FTC participants, with detectable drug levels compared to placebo. Conclusions: TDF/FTC for PrEP showed cholesterol reductions and appeared to transiently suppress the accumulation of weight and body fat compared to placebo. There was no evidence of altered fat distribution or lipodystrophy during daily oral TDF/FTC PrEP. Clinical Trials Registration: NCT00458393.

Indexed as

Pre-Exposure ProphylaxisAbsorptiometry, PhotonAdiposityAdministration, OralAdultAnti-HIV AgentsBody Mass IndexBody WeightDouble-Blind MethodEmtricitabineFemaleHIV InfectionsHumansLipid MetabolismLipidsMaleAnti-HIV AgentsEmtricitabineLipidsTenofovir

Identifiers

PMID29415175
PMCPMC6051460
OpenAlexW2789678217

What OpenQuestion holds

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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.