Evidence map›Paper›PMID 21091279›Full record

Trial reportThe New England journal of medicine2010

Preexposure chemoprophylaxis for HIV prevention in men who have sex with men.

Robert M Grant, Javier R Lama, Peter L Anderson, Vanessa McMahan, Albert Y Liu, Lorena Vargas, Pedro Goicochea, Martín Casapía, Juan Vicente Guanira-Carranza, Maria E Ramirez-Cardich and 26 more

20 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 20 registered trials, which are not on this map. Cited by 2,889 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2,889citing papers in PubMed, 9 pooled it
140.0field-weighted citation impact, top 1% 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
NCT01327651 phase2completednot on this mapstarted 2011, after this paper: background citation

The ADAPT Study: A Phase II, Randomized, Open-Label, Pharmacokinetic and Behavioral Study of the Use of Intermittent Oral Emtricitabine/Tenofovir Disoproxil Fumarate Pre-Exposure Prophylaxis (PrEP) Pre-Exposure Prophylaxis (PrEP)

TypeinterventionalSponsorHIV Prevention Trials NetworkRan2011 to 2014Enrolled622ConditionsHIV InfectionsArmsDaily dosing, Time-driven dosing, Event-driven dosing
NCT01505114 phase2completednot on this mapstarted 2012, after this paper: background citation

A Phase II Randomized, Double-Blind, Study of the Safety and Tolerability of Maraviroc (MVC), Maraviroc + Emtricitabine (MVC+FTC), Maraviroc + Tenofovir Disoproxil Fumarate (MVC+TDF), or Tenofovir Disoproxil Fumarate + Emtricitabine (TDF+FTC) For Pre-Exposure Prophylaxis (PrEP) To Prevent HIV Transmission in At-Risk Men Who Have Sex With Men and in At-Risk Women

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2012 to 2015Enrolled594ConditionsHIV InfectionArmsMaraviroc, Emtricitabine, Tenofovir disoproxil fumarate, Maraviroc placebo, Emtricitabine placebo
NCT01632995 nacompletednot on this mapstarted 2012, after this paper: background citation

Implementation of HIV Pre-exposure Prophylaxis (PrEP): A Demonstration Project

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2012 to 2015Enrolled557ConditionsHIV InfectionsArmsFTC 200 mg/TDF 300 mg fixed-dose combination tablet
NCT02165202 phase2completednot on this mapstarted 2014, after this paper: background citation

HPTN 076 - Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278 LA, for Pre-Exposure Prophylaxis (PrEP)

TypeinterventionalSponsorPATHRan2014 to 2017Enrolled136ConditionsHuman Immunodeficiency Virus (HIV)ArmsRilpivirine, Placebo
NCT02183909 nacompletednot on this mapstarted 2013, after this paper: background citation

Connecting Resources for Urban Sexual Health

TypeinterventionalSponsorUniversity of California, San FranciscoRan2013 to 2017Enrolled378ConditionsHIV, Sexually Transmitted InfectionsArmsTesting and linkage to care for Y/MSM, Engagement and retention for HIV-positive Y/MSM in care, Engagement and retention for HIV-negative Y/MSM in sexual health services, Stribild PEP Substudy
NCT02611362 nacompletednot on this mapstarted 2015, after this paper: background citation

A Multilevel Gaming Intervention for Persons on PrEP

TypeinterventionalSponsorRhode Island HospitalRan2015 to 2019Enrolled82ConditionsMSM, PrEP, HIV RiskArmsIMB Gaming Intervention
NCT02864550 phase4completednot on this mapstarted 2019, after this paper: background citation

A Randomized, Placebo-controlled Trial of Oral Doxycycline for the Prevention of Syphilis in HIV-positive Men Who Have Sex with Men (MSM)

TypeinterventionalSponsorBritish Columbia Centre for Disease ControlRan2019 to 2024Enrolled52ConditionsSyphilis, Sexually Transmitted InfectionsArmsDoxycycline, Placebo
NCT02921841 nacompletednot on this mapstarted 2016, after this paper: background citation

Digital Star: HIV Prevention for Youth in Mental Health Treatment

TypeinterventionalSponsorRhode Island HospitalRan2016 to 2019Enrolled125ConditionsHuman Immunodeficiency Virus, Mental HealthArmsD*STAR, D*HEALTH
NCT03043326 unknown statusnot on this mapstarted 2017, after this paper: background citation

Demonstration Project on the Feasibility to Implement a Pre-Exposure Oral Prophylaxis Program in Men Who Have Sex With Other Men and Transgender Women at Risk of Acquiring HIV

TypeobservationalSponsorAsociación Civil Impacta Salud y Educación, PeruRan2017 to 2022Enrolled1,000ConditionsHIV PreventionArmsTenofovir Disoproxil Fumarate and Emtricitabine
NCT03205566 phase4completednot on this mapstarted 2017, after this paper: background citation

The Time to Protection and Adherence Requirements of Raltegravir With or Without Lamivudine in Protection From HIV Infection

TypeinterventionalSponsorGuy's and St Thomas' NHS Foundation TrustRan2017 to 2018Enrolled38ConditionsHivArmsRaltegravir 400Mg Tab, Lamivudine 150Mg Tablet
NCT03429842 completednot on this mapstarted 2015, after this paper: background citation

HIV Awal (Early) Testing & Treatment Indonesia Project Implementing 'Test and Treat' Strategies for HIV Treatment and Prevention in Key Populations in Indonesia: a Prospective Implementation Research Study (Phase 1 - Observational Phase)

TypeobservationalSponsorGadjah Mada UniversityRan2015 to 2017Enrolled2,071ConditionsHIV/AIDS
NCT04048382 nacompletednot on this mapstarted 2019, after this paper: background citation

Developing a Patient Navigation Intervention for PrEP Continuum of Care Among Young Latino MSM (PrEParate)

TypeinterventionalSponsorSan Diego State UniversityRan2019 to 2021Enrolled57ConditionsHIV/AIDSArmsPatient Navigation, Usual Care
NCT04050371 phase4completednot on this mapstarted 2017, after this paper: background citation

I-BrEATHe - Interactions Between Antiretrovirals And Transgender Hormones

TypeinterventionalSponsorUniversity of California, San FranciscoRan2017 to 2018Enrolled48ConditionsHIV Prevention, Transgender HealthArms200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
NCT04523519 phase4unknown statusnot on this mapstarted 2021, after this paper: background citation

PrEP Intervention for People Who Inject Substances and Use Methamphetamine

TypeinterventionalSponsorSan Francisco Department of Public HealthRan2021 to 2025Enrolled140ConditionsHIV InfectionsArmsVideo directly observed therapy with contingency management, Integrated Next-Step Counseling
NCT04772469 nacompletednot on this mapstarted 2021, after this paper: background citation

Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men

TypeinterventionalSponsorUniversity of California, San FranciscoRan2021 to 2023Enrolled934ConditionsHuman Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, HIV Infections, Sexually Transmitted Diseases, ViralArmsProvision of multiple self-tests, Small monetary incentives, Use of SMS/text reminders to motivate adherence to ART or PrEP
NCT05333679 nacompletednot on this mapstarted 2022, after this paper: background citation

Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study)

TypeinterventionalSponsorUniversity of California, San FranciscoRan2022 to 2025Enrolled200ConditionsRisk ReductionArmsUTRA, UTRA feedback
NCT05492565 enrolling by invitationnot on this mapstarted 2020, after this paper: background citation

A Study to Evaluate Clinical Benefits and Drawbacks of Antiretroviral Drugs as Pre-exposure Prophylaxis to Prevent HIV Infection Under Real-life Conditions Among Persons Who Pursue High-risk Sexual Practices: The Seville HIV PrEP Cohort

Typeobservational_patient_registrySponsorHospitales Universitarios Virgen del RocíoRan2020 to 2030Enrolled500ConditionsHIV Infection Primary, Hepatitis, Viral, Human, Sexually Transmitted Infections, Excluding HIV and HepatitisArmsTenofovir Disoproxil Fumarate 300 MG Oral Tablet
NCT06159582 nacompletednot on this mapstarted 2024, after this paper: background citation

eSTEP: An Integrated mHealth Intervention to Engage High-risk Individuals Along the Full PrEP Care Continuum

TypeinterventionalSponsorSan Diego State UniversityRan2024 to 2025Enrolled113ConditionsPre-Exposure Prophylaxis (PrEP)ArmseSTEP, Usual Care
NCT06860945 recruitingnot on this mapstarted 2025, after this paper: background citation

Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain

Typeobservational_patient_registrySponsorHospital Universitario de ValmeRan2025 to 2026Enrolled9,000ConditionsSexually Transmitted Infections (STIs), HIV, PrEPArmsNo Intervention: Observational Cohort
3 · Its place in the literature

Who cites it

2,889 citing papers in PubMed, 9 syntheses or guidelines pooled it, 5,092 citations in OpenAlex.

  1. Pooled it
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  4. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2025
    Guideline
  5. Canadian guideline on HIV pre- and postexposure prophylaxis: 2025 update.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2025
    Guideline
  6. Pooled it
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  9. Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV - CDC Recommendations, United States, 2025.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2025
    Guideline
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2,829 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

36 authors at 19 institutions in 7 countries.

Robert M GrantJ. David Gladstone Institutes, University of California at San Francisco, 1650 Owens St., San Francisco, CA 94158, USA. robert.grant@ucsf.edu
Javier R Lama
Peter L Anderson
Vanessa McMahan
Albert Y Liu
Lorena Vargas
Pedro Goicochea
Martín Casapía
Juan Vicente Guanira-Carranza
Maria E Ramirez-Cardich
Orlando Montoya-Herrera
Telmo Fernández
Valdilea G Veloso
Susan P Buchbinder
Suwat Chariyalertsak
Mauro Schechter
Linda-Gail Bekker
Kenneth H Mayer
Esper Georges Kallás
K Rivet Amico
Kathleen Mulligan
Lane R Bushman
Robert J Hance
Carmela Ganoza
Patricia Defechereux
Brian Postle
Furong Wang
J Jeff McConnell
Jia-Hua Zheng
Jeanny Lee
James F Rooney
Howard S Jaffe
Ana I Martinez
David N Burns
David V Glidden
iPrEx Study Team
Institute of Virology of the Slovak Academy of Sciences · SKAsociación Civil Impacta Salud y Educación · PEUniversity of California, San Francisco · USUniversity of Colorado Denver · USGilead Sciences (United States) · USInstituto Ecuatoriano de Enfermedades Digestivas · ECAsociación para la Conservación de la Cuenca Amazónica · PEBrighton Hospital · USBrown University · USChiang Mai University · THDesmond Tutu HIV Foundation · ZAEsSALUD · PEFundação Oswaldo Cruz · BRGladstone Institutes · USNational Institute of Allergy and Infectious Diseases · USNational Institutes of Health · USSan Francisco Department of Public Health · USUniversidade de São Paulo · BRUniversidade Federal do Rio de Janeiro · BR

Funding

UCSF CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTEUL1RR024131 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JOHNSTON, S. CLAIBORNE · 2006 to 2011
$111.2M
Chemoprophylaxis for HIV Prevention in Men SupplementU01AI064002 · NIAID · J. DAVID GLADSTONE INSTITUTES · PI GRANT, ROBERT M. · 2005 to 2011
$41.3M
Chemoprophylaxis and HIV-Host InteractionsR01AI062333 · NIAID · J. DAVID GLADSTONE INSTITUTES · PI GRANT, ROBERT M. · 2004 to 2011
$6.2M
Cellular pharmacology of tenofovir and emtricitabine for HIV prophylaxisU01AI084735 · NIAID · UNIVERSITY OF COLORADO DENVER · PI ANDERSON, PETER L. · 2009 to 2012
$4.2M
Chemoprophylaxis and HIV Host InteractionsR01AI118575 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANT, ROBERT M. · 2015 to 2019
$2.9M
NCRR NIH HHS UL1 RR024131NIAID NIH HHS R01 AI062333NIAID NIH HHS R01 AI118575NIAID NIH HHS U01 AI064002NIAID NIH HHS U01 AI084735NIAID NIH HHS U01 AI64002NIAID NIH HHS U01 AI84735
6 · The paper itself

Abstract

backgroundAntiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition.

methodsWe randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC-TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections.

resultsThe study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC-TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P=0.005). In the FTC-TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC-TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P=0.57).

conclusionsOral FTC-TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT00458393.).

Indexed as

Homosexuality, MaleAdenineAdministration, OralAdolescentAdultAnti-HIV AgentsDeoxycytidineDrug Resistance, ViralDrug Therapy, CombinationEmtricitabineFollow-Up StudiesHIVHIV AntibodiesHIV InfectionsHIV SeropositivityHumansAdenineAnti-HIV AgentsDeoxycytidineEmtricitabineHIV AntibodiesOrganophosphonatesRNA, ViralTenofovir

Identifiers

PMID21091279
PMCPMC3079639
OpenAlexW2103920597

What OpenQuestion holds

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Registered trials

and 14 more above

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.