Tenofovir DF-Emtricitabine (Truvada and Multiple Generics)

Other Names: TDF-FTC, Tenofovir disoproxil fumarate-Emtricitabine

All Clinical Trials

All Clinical Trials
Clinical Studies
- Treatment-Naive
- Treatment-Experienced
- Switch/Simplification
- Dual Therapy
- Monotherapy
- PREP
- PEP
- Acute HIV
Resistance/Virological Failure
Pharmacology
- General Pharmacology
- Adverse Effects
- Drug Interactions
Pregnancy/Women
Pediatrics
Review

ACTG 5202 Non-Industry

Official Title A Phase IIIB, Randomized Trial of Open-Label Efavirenz or Atazanavir With Ritonavir in Combination With Double-Blind Comparison of Emtricitabine/Tenofovir or Abacavir/Lamivudine in Antiretroviral-Naive Subjects

Phase Phase IIIB

ClinicalTrials.gov NCT00118898

Treatments

Abacavir

Tradename:ZiagenOther Names:ABCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Abacavir-Lamivudine

Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Efavirenz

Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Categories Treatment-NaiveResistance/Virological FailurePregnancy/Women

Funding

Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)

References

Daar ES, Tierney C, Fischl MA, et al. Atazanavir plus ritonavir or efavirenz as part of a 3-drug regimen for initial treatment of HIV-1. Ann Intern Med. 2011;154:445-56.
[PubMed Abstract]
Smith KY, Tierney C, Mollan K, et al. Outcomes by sex following treatment initiation with atazanavir plus ritonavir or efavirenz with abacavir/lamivudine or tenofovir/emtricitabine. Clin Infect Dis. 2014;58:555-63.
[PubMed Abstract]

ACTG 5224s Non-Industry

Phase Phase IIIB

ClinicalTrials.gov NCT00118898

Treatments

Abacavir-Lamivudine

Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Categories PharmacologyAdverse EffectsTreatment-Naive

Funding

Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)

References

Longenecker CT, Kitch D, Sax PE, et al. Reductions in Plasma Cystatin C After Initiation of antiretroviral therapy are associated with reductions in inflammation: ACTG A5224s. J Acquir Immune Defic Syndr. 2015;69:168-77.
[PubMed Abstract]
McComsey GA, Daar ES, O'Riordan M, et al. Changes in fat mitochondrial DNA and function in subjects randomized to abacavir-lamivudine or tenofovir DF-emtricitabine with atazanavir-ritonavir or efavirenz: AIDS Clinical Trials Group study A5224s, substudy of A5202. J Infect Dis. 2013;207:604-11.
[PubMed Abstract]
McComsey GA, Kitch D, Daar ES, et al. Bone mineral density and fractures in antiretroviral-naive persons randomized to receive abacavir-lamivudine or tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-ritonavir: Aids Clinical Trials Group A5224s, a substudy of ACTG A5202. J Infect Dis. 2011;203:1791-801.
[PubMed Abstract]
McComsey GA, Kitch D, Sax PE, et al. Peripheral and central fat changes in subjects randomized to abacavir-lamivudine or tenofovir-emtricitabine with atazanavir-ritonavir or efavirenz: ACTG Study A5224s. Clin Infect Dis. 2011;53:185-96.
[PubMed Abstract]

ASSERT Industry

Official Title Study of Once-Daily Abacavir/Lamivudine Versus Tenofovir/Emtricitabine, Administered With Efavirenz in Antiretroviral-Naive, HIV-1 Infected Adult Subjects

Phase Phase IV

ClinicalTrials.gov NCT00549198

Treatments

Abacavir-Lamivudine

Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Efavirenz

Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Efavirenz-Tenofovir DF-Emtricitabine

Tradename:AtriplaOther Names:EFV-TDF-FTC, Efavirenz-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet Regimens

Categories PharmacologyTreatment-NaiveAdverse Effects

Funding

IndustryGlaxoSmithKline

References

Moyle GJ, Stellbrink HJ, Compston J, et al. 96-Week results of abacavir/lamivudine versus tenofovir/emtricitabine, plus efavirenz, in antiretroviral-naive, HIV-1-infected adults: ASSERT study. Antivir Ther. 2013;18:905-13.
[PubMed Abstract]
Post FA, Moyle GJ, Stellbrink HJ, et al. Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study. J Acquir Immune Defic Syndr. 2010;55:49-57.
[PubMed Abstract]
Stellbrink HJ, Orkin C, Arribas JR, et al. Comparison of changes in bone density and turnover with abacavir-lamivudine versus tenofovir-emtricitabine in HIV-infected adults: 48-week results from the ASSERT study. Clin Infect Dis. 2010;51:963-72.
[PubMed Abstract]

ATN 110 Non-Industry

Official Title Project PrEPare - An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among Young Men Who Have Sex With Men (YMSM) in the United States

ClinicalTrials.gov NCT01772823

Treatments

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Funding

Non-IndustryUniversity of North Carolina

References

Hosek SG, Rudy B, Landovitz R, et al. An HIV Preexposure Prophylaxis Demonstration Project and Safety Study for Young MSM. J Acquir Immune Defic Syndr. 2017;74:21-9.
[PubMed Abstract]

ATN 113 Non-Industry

Official Title Project PrEPare - An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM) in the United States

Phase Phase II

ClinicalTrials.gov NCT01769456

Treatments

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Funding

Non-IndustryUniversity of North Carolina

References

Hosek SG, Landovitz RJ, Kapogiannis B, et al. Safety and Feasibility of Antiretroviral Preexposure Prophylaxis for Adolescent Men Who Have Sex With Men Aged 15 to 17 Years in the United States. JAMA Pediatr. 2017;171:1063-71.
[PubMed Abstract]

COMET Industry

Official Title Combination of Efavirenz & Truvada (COMET Study): Phase 4 Evaluation of Switching Twice Daily Combivir to Once-Daily Regimen Co-Formulated Truvada in Virologically Suppressed HIV Infected Patients Taking Efavirenz.

Phase Phase IV

ClinicalTrials.gov NCT00224458

Treatments

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Categories Treatment-ExperiencedSwitch/Simplification

Funding

IndustryGilead Sciences

References

DeJesus E, Ruane P, McDonald C, et al. Impact of switching virologically suppressed, HIV-1-infected patients from twice-daily fixed-dose zidovudine/lamivudine to once-daily fixed-dose tenofovir disoproxil fumarate/emtricitabine. HIV Clin Trials. 2008;9:103-14.
[PubMed Abstract]

FEM-PrEP Non-Industry

Official Title Phase 3, Multi-center, Double-blind, Randomized, Placebo-controlled Effectiveness and Safety Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women

Phase Phase III

ClinicalTrials.gov NCT00625404

Treatments

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Categories PREP

Funding

Non-IndustryU.S. Agency for International Development and the Bill and Melinda Gates Foundation

References

Van Damme L, Corneli A, Ahmed K, et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2012;367:411-22.
[PubMed Abstract]

HEAT Industry

Official Title A 96-Week, Phase IV, Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of EPZICOM Versus TRUVADA Administered in Combination With KALETRA in Antiretroviral-Naive HIV-1 Infected Subjects

Phase Phase IV

ClinicalTrials.gov NCT00244712

Treatments

Abacavir-Lamivudine

Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Lopinavir-Ritonavir

Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Categories Treatment-Naive

Funding

IndustryGlaxoSmithKline

References

Smith KY, Patel P, Fine D, et al. Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatment. AIDS. 2009;23:1547-56.
[PubMed Abstract]

IPERGAY Non-Industry

Official Title On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men

Phase Phase III

ClinicalTrials.gov NCT01473472

Treatments

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Categories PharmacologyGeneral PharmacologyPREP

Funding

Non-IndustryFrench National Institute for Health and Medical Research-French National Agency for Research on AID

References

Fonsart J, Saragosti S, Taouk M, et al. Single-dose pharmacokinetics and pharmacodynamics of oral tenofovir and emtricitabine in blood, saliva and rectal tissue: a sub-study of the ANRS IPERGAY trial. J Antimicrob Chemother. 2017;72:478-485.
[PubMed Abstract]
Molina JM, Capitant C, Spire B, et al. On-demand preexposure prophylaxis in men at high risk for HIV-1 infection. N Engl J Med. 2015;373:2237-46.
[PubMed Abstract]
Sagaon-Teyssier L, Suzan-Monti M, Demoulin B, et al. Uptake of PrEP and condom and sexual risk behavior among MSM during the ANRS IPERGAY trial. AIDS Care. 2016;28 Suppl 1:48-55.
[PubMed Abstract]

IPrEx Non-Industry

Official Title Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men (iPrEx)

Phase Phase III

ClinicalTrials.gov NCT00458393

Treatments

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Categories PREP

Funding

Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID); Bill & Melinda Gates Foundation

References

Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363:2587-99.
[PubMed Abstract]

iPrEx Subgroup Analysis in Transgender Women Non-Industry Industry

Official Title HIV pre-exposure prophylaxis in transgender women: A subgroup analysis of the iPrEx trial

Phase Phase III

Treatments

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Categories PREP

Funding

IndustryGilead Sciences

Non-IndustryBill & Melinda Gates Foundation; National Institute of Allergy and Infectious Diseases (NIAID)

References

Deutsch MB, Glidden DV, Sevelius J, et al. HIV pre-exposure prophylaxis in transgender women: a subgroup analysis of the iPrEx trial. Lancet HIV. 2015;2:e512-9.
[PubMed Abstract]

Partners PrEP Non-Industry

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

Phase Phase III

ClinicalTrials.gov NCT00557245

Treatments

Tenofovir DF

Tradename:VireadOther Names:TDF, tenofovir disoproxil fumarateClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Categories PREPPregnancy/Women

Funding

Non-IndustryBill & Melinda Gates Foundation

References

Baeten JM, Donnell D, Mugo NR, et al. Single-agent tenofovir versus combination emtricitabine plus tenofovir for pre-exposure prophylaxis for HIV-1 acquisition: an update of data from a randomised, double-blind, phase 3 trial. Lancet Infect Dis. 2014;14:1055-64.
[PubMed Abstract]
Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367:399-410.
[PubMed Abstract]
Celum C, Morrow RA, Donnell D, et al. Daily oral tenofovir and emtricitabine-tenofovir preexposure prophylaxis reduces herpes simplex virus type 2 acquisition among heterosexual HIV-1-uninfected men and women: a subgroup analysis of a randomized trial. Ann Intern Med. 2014;161:11-9.
[PubMed Abstract]
Mugo NR, Hong T, Celum C, et al. Pregnancy incidence and outcomes among women receiving preexposure prophylaxis for HIV prevention: a randomized clinical trial. JAMA. 2014;312:362-71.
[PubMed Abstract]

PROUD Non-Industry Industry

Official Title Pre-exposure Option for Reducing HIV in the UK: an Open-label Randomisation to Immediate or Deferred Daily Truvada for HIV Negative Gay Men.(PROUD)

Phase Phase IV

ClinicalTrials.gov NCT02065986

Treatments

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Categories PREP

Funding

IndustryGilead Sciences

Non-IndustryMedical Research Council (MRC)

References

Dolling DI, Desai M, McOwan A, et al. An analysis of baseline data from the PROUD study: an open-label randomised trial of pre-exposure prophylaxis. Trials. 2016;17:163.
[PubMed Abstract]
McCormack S, Dunn DT, Desai M, et al. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial. Lancet. 2016;387:53-60.
[PubMed Abstract]

RECOMB Industry

Official Title Pilot Phase IV, Multicenter, Randomized, Open-label and Controlled Study to Assess the Evolution of Peripheral Body Fat Distribution After Switching From Zidovudine Containing Backbone to Truvada in HIV-1-infected Patients on HAART (RECOMB Study).

Phase Phase IV

ClinicalTrials.gov NCT00324649

Treatments

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Categories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects

Funding

IndustryGilead Sciences

References

Martínez E, Ribera E, Clotet B, et al. Switching from zidovudine/lamivudine to tenofovir/emtricitabine improves fat distribution as measured by fat mass ratio. HIV Med. 2015;16:370-4.
[PubMed Abstract]
Ribera E, Larrousse M, Curran A, et al. Impact of switching from zidovudine/lamivudine to tenofovir/emtricitabine on lipoatrophy: the RECOMB study. HIV Med. 2013;14:327-36.
[PubMed Abstract]

ROCKET I Industry

Official Title A Phase 4, Open Label, Randomized, Controlled Study to Assess the Effect on Lipid Profile of Switching From a Stable HAART Regimen of Fixed Dose Abacavir/Lamivudine (Kivexa) Plus Efavirenz, to Once Daily Atripla in Adult HIV-1 Infected Subjects With Raised Cholesterol

Phase Phase IV

ClinicalTrials.gov NCT00615810

Treatments

Abacavir-Lamivudine

Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Efavirenz

Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Categories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects

Funding

IndustryGilead Sciences

References

Moyle GJ, Orkin C, Fisher M, et al. A randomized comparative trial of continued abacavir/lamivudine plus efavirenz or replacement with efavirenz/emtricitabine/tenofovir DF in hypercholesterolemic HIV-1 infected individuals. PLoS One. 2015;10:e0116297.
[PubMed Abstract]

ROCKET II Industry

Official Title A Phase 4, Open Label, Randomized, Controlled Study to Assess the Effect on Lipid Profile of Switching a Stable HAART Regimen of Fixed Dose Abacavir/Lamivudine (Kivexa) Plus Lopinavir/Ritonavir (Kaletra), to Emtricitabine/Tenofovir Disoproxil Fumarate (Truvada) Plus Lopinavir/Ritonavir (Kaletra) in Adult HIV-1 Infected Subjects With Raised Cholesterol

Phase Phase IV

ClinicalTrials.gov NCT00772902

Treatments

Abacavir-Lamivudine

Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Lopinavir-Ritonavir

Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Categories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects

Funding

IndustryGilead Sciences

References

Behrens G, Maserati R, Rieger A, et al. Switching to tenofovir/emtricitabine from abacavir/lamivudine in HIV-infected adults with raised cholesterol: effect on lipid profiles. Antivir Ther. 2012;17:1011-20.
[PubMed Abstract]

SONETT Industry

Official Title Switch to a Completely ONce Daily Regimen Containing Emtricitabine/Tenofovir - Fixed Dose Combination Plus Third QD Partner: "SONETT"

Phase Phase IV

ClinicalTrials.gov NCT00323687

Treatments

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Categories Treatment-ExperiencedSwitch/Simplification

Funding

IndustryGilead Sciences

References

Arasteh K, Weitner L, Fenske S, et al. Switch from a ZDV/3TC-based regimen to a completely once daily (QD) regimen of emtricitabine/tenofovir DF fixed dose combination plus a third QD agent (SONETT). Eur J Med Res. 2009;14:195-9.
[PubMed Abstract]

STEAL Non-Industry

Official Title A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study.

Phase Phase IV

ClinicalTrials.gov NCT00192634

Treatments

Abacavir-Lamivudine

Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Categories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects

Funding

Non-IndustryKirby Institute

References

Haskelberg H, Hoy JF, Amin J, et al. Changes in bone turnover and bone loss in HIV-infected patients changing treatment to tenofovir-emtricitabine or abacavir-lamivudine. PLoS One. 2012;7:e38377.
[PubMed Abstract]
Haskelberg H, Pocock N, Amin J, et al. Hip structural parameters over 96 weeks in HIV-infected adults switching treatment to tenofovir-emtricitabine or abacavir-lamivudine. PLoS One. 2014;9:e94858.
[PubMed Abstract]
Martin A, Bloch M, Amin J, et al. Simplification of antiretroviral therapy with tenofovir-emtricitabine or abacavir-Lamivudine: a randomized, 96-week trial. Clin Infect Dis. 2009;49:1591-601.
[PubMed Abstract]

SWAP Industry

Official Title Efficacy and Safety of Switching From AZT to Tenofovir

Phase Phase IV

ClinicalTrials.gov NCT00647244

Treatments

Abacavir-Lamivudine

Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Categories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects

Funding

IndustryGlaxoSmithKline

References

Rasmussen TA, Jensen D, Tolstrup M, et al. Comparison of bone and renal effects in HIV-infected adults switching to abacavir or tenofovir based therapy in a randomized trial. PLoS One. 2012;7:e32445.
[PubMed Abstract]
Rasmussen TA, Tolstrup M, Melchjorsen J, et al. Evaluation of cardiovascular biomarkers in HIV-infected patients switching to abacavir or tenofovir based therapy. BMC Infect Dis. 2011;11:267.
[PubMed Abstract]

SWEET Industry

Official Title A Phase 3, Open Label, Randomised, Parallel Group Study to Compare the Effect on Prevention and Resolution of Treatment Related Adverse Events of a Simplified, Once Daily Regimen of a Fixed Dose Combination Tablet of Emtricitabine and Tenofovir DF Versus Twice Daily co-Formulated Zidovudine and Lamivudine (Combivir®) or Zidovudine and Lamivudine, in Virologically Suppressed, HIV Infected Patients Taking Efavirenz

Phase Phase III

ClinicalTrials.gov NCT00323544

Treatments

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Zidovudine-Lamivudine

Tradename:CombivirOther Names:ZDV-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Efavirenz-Tenofovir DF-Emtricitabine

Tradename:AtriplaOther Names:EFV-TDF-FTC, Efavirenz-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet Regimens

Categories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects

Funding

IndustryGilead Sciences

References

Fisher M, Moyle GJ, Shahmanesh M, et al. A randomized comparative trial of continued zidovudine/lamivudine or replacement with tenofovir disoproxil fumarate/emtricitabine in efavirenz-treated HIV-1-infected individuals. J Acquir Immune Defic Syndr. 2009;51:562-8.
[PubMed Abstract]

SWIFT Industry

Official Title A Prospective, Randomized, Open Label Phase IV Study to Evaluate the Rationale of Switching From Fixed Dose Abacavir (ABC)/Lamivudine (3TC) to Fixed Dose Tenofovir DF (TDF)/Emtricitabine (FTC) in Virologically Suppressed, HIV-1 Infected Patients Maintained on a Ritonavir Boosted Protease Inhibitor Containing Antiretroviral Regimen

Phase Phase IV

ClinicalTrials.gov NCT00724711

Treatments

Abacavir-Lamivudine

Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Categories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects

Funding

IndustryGilead Sciences

References

Campo R, DeJesus E, Bredeek UF, et al. SWIFT: prospective 48-week study to evaluate efficacy and safety of switching to emtricitabine/tenofovir from lamivudine/abacavir in virologically suppressed HIV-1 infected patients on a boosted protease inhibitor containing antiretroviral regimen. Clin Infect Dis. 2013;56:1637-45.
[PubMed Abstract]

TDF2 Non-Industry

Official Title Study of the Safety and Efficacy of Daily Oral Antiretroviral Use for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana

Phase Phase III

ClinicalTrials.gov NCT00448669

Treatments

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Categories Resistance/Virological FailurePREPPharmacologyPregnancy/WomenGeneral PharmacologyAdverse Effects

Funding

Non-IndustryCenters for Disease Control and Prevention

References

Chirwa LI, Johnson JA, Niska RW, et al. CD4(+) cell count, viral load, and drug resistance patterns among heterosexual breakthrough HIV infections in a study of oral preexposure prophylaxis. AIDS. 2014;28:223-6.
[PubMed Abstract]
Colbers AP, Hawkins DA, Gingelmaier A, et al. The pharmacokinetics, safety and efficacy of tenofovir and emtricitabine in HIV-1-infected pregnant women. AIDS. 2013;27:739-48.
[PubMed Abstract]
Kasonde M, Niska RW, Rose C, et al. Bone mineral density changes among HIV-uninfected young adults in a randomised trial of pre-exposure prophylaxis with tenofovir-emtricitabine or placebo in Botswana. PLoS One. 2014;9:e90111.
[PubMed Abstract]
Kebaabetswe PM, Stirratt MJ, McLellan-Lemal E, et al. Factors Associated with Adherence and Concordance Between Measurement Strategies in an HIV Daily Oral Tenofovir/Emtricitibine as Pre-exposure Prophylaxis (Prep) Clinical Trial, Botswana, 2007-2010. AIDS Behav. 2015;19:758-69.
[PubMed Abstract]
Thigpen MC, Kebaabetswe PM, Paxton LA, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012;367:423-34.
[PubMed Abstract]

TOTEM Industry

Official Title Open-label Randomized Multicenter Trial to Evaluate the Impact on the Lipid Profile of the Substitution of the NRTIs of a HAART Regimen by a Once Daily Fixed Dose Combination Tablet of Emtricitabine and Tenofovir DF Versus Maintained Treatment in HIV Infected Controlled Patients.

Phase Phase IV

ClinicalTrials.gov NCT00323492

Treatments

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Categories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects

Funding

IndustryGilead Sciences

References

Valantin MA, Bittar R, de Truchis P, et al. Switching the nucleoside reverse transcriptase inhibitor backbone to tenofovir disoproxil fumarate + emtricitabine promptly improves triglycerides and low-density lipoprotein cholesterol in dyslipidaemic patients. J Antimicrob Chemother. 2010;65:556-61.
[PubMed Abstract]

VOICE Non-Industry

Official Title Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women

Phase Phase IIB

ClinicalTrials.gov NCT00705679

Treatments

Tenofovir DF

Tradename:VireadOther Names:TDF, tenofovir disoproxil fumarateClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Tenofovir DF-Emtricitabine

Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Categories PREP

Funding

Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)

References

Dai JY, Hendrix CW, Richardson BA, et al. Pharmacological Measures of Treatment Adherence and Risk of HIV Infection in the VOICE Study. J Infect Dis. 2016;213:335-42.
[PubMed Abstract]
Marrazzo JM, Ramjee G, Richardson BA, et al. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2015;372:509-18.
[PubMed Abstract]
Moodley J, Naidoo S, Moodley J, Ramjee G. Sharing of Investigational Drug Among Participants in the Voice Trial. AIDS Behav. 2016;20:2709-2714.
[PubMed Abstract]
Noguchi LM, Richardson BA, Baeten JM, et al. Risk of HIV-1 acquisition among women who use diff erent types of injectable progestin contraception in South Africa: a prospective cohort study. Lancet HIV. 2015;2:e279-87.
[PubMed Abstract]
van der Straten A, Brown ER, Marrazzo JM, et al. Divergent adherence estimates with pharmacokinetic and behavioural measures in the MTN-003 (VOICE) study. J Int AIDS Soc. 2016;19:20642.
[PubMed Abstract]