Bictegravir-Tenofovir alafenamide-Emtricitabine Biktarvy
Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine Symtuza
Dolutegravir-Abacavir-Lamivudine Triumeq
Dolutegravir-Lamivudine Dovato
Dolutegravir-Rilpivirine Juluca
Doravirine-Tenofovir DF-Lamivudine Delstrigo
Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine Genvoya
Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine Stribild
Rilpivirine-Tenofovir alafenamide-Emtricitabine Odefsey
Rilpivirine-Tenofovir DF-Emtricitabine Complera
Enfuvirtide Fuzeon
Fostemsavir Rukobia
Ibalizumab Trogarzo
Maraviroc Selzentry
Dolutegravir Tivicay
Raltegravir Isentress
Abacavir-Lamivudine-Zidovudine Trizivir
Didanosine Videx
Emtricitabine Emtriva
Lamivudine Epivir
Stavudine Zerit
Tenofovir alafenamide-Emtricitabine Descovy
Zidovudine Retrovir
Doravirine Pifeltro
Etravirine Intelence
Nevirapine Viramune
Rilpivirine Edurant
Atazanavir Reyataz
Atazanavir-Cobicistat Evotaz
Darunavir Prezista
Darunavir-Cobicistat Prezcobix
Fosamprenavir Lexiva
Indinavir Crixivan
Nelfinavir Viracept
Saquinavir Invirase
Tipranavir Aptivus
Cobicistat Tybost
Ritonavir Norvir Share
Tenofovir DF-Emtricitabine (Truvada and Multiple Generics)
Other Names: TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineAll Clinical Trials
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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
, Abacavir
Tradename:ZiagenOther Names:ABCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Abacavir-Lamivudine
, Abacavir-Lamivudine
Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Efavirenz
, Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Tenofovir DF-Emtricitabine
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.
- 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.
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-Lamivudine
, Abacavir-Lamivudine
Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Tenofovir DF-Emtricitabine
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.
- 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.
- 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.
- 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.
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
, Abacavir-Lamivudine
Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Efavirenz
, Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Tenofovir DF-Emtricitabine
, Tenofovir DF-Emtricitabine
Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Efavirenz-Tenofovir DF-Emtricitabine
Efavirenz-Tenofovir DF-Emtricitabine
Tradename:AtriplaOther Names:EFV-TDF-FTC, Efavirenz-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet RegimensCategories 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.
- 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.
- 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.
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
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.
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
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.
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
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.
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
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.
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
, Abacavir-Lamivudine
Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Lopinavir-Ritonavir
, Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Tenofovir DF-Emtricitabine
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.
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
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.
- 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.
- 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.
Official Title Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men (iPrEx)
Phase Phase III
ClinicalTrials.gov NCT00458393
Treatments
Tenofovir DF-Emtricitabine
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.
Official Title HIV pre-exposure prophylaxis in transgender women: A subgroup analysis of the iPrEx trial
Phase Phase III
Treatments
Tenofovir DF-Emtricitabine
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.
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
, Tenofovir DF
Tradename:VireadOther Names:TDF, tenofovir disoproxil fumarateClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Tenofovir DF-Emtricitabine
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.
- 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.
- 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.
- 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.
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
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.
- 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.
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
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
- MartÃnez 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.
- 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.
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
, Abacavir-Lamivudine
Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Efavirenz
, Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Tenofovir DF-Emtricitabine
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.
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
, Abacavir-Lamivudine
Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Lopinavir-Ritonavir
, Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Tenofovir DF-Emtricitabine
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.
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
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.
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
, Abacavir-Lamivudine
Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Tenofovir DF-Emtricitabine
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.
- 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.
- 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.
Official Title Efficacy and Safety of Switching From AZT to Tenofovir
Phase Phase IV
ClinicalTrials.gov NCT00647244
Treatments
Abacavir-Lamivudine
, Abacavir-Lamivudine
Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Tenofovir DF-Emtricitabine
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.
- 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.
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
, Tenofovir DF-Emtricitabine
Tradename:Truvada and Multiple GenericsOther Names:TDF-FTC, Tenofovir disoproxil fumarate-EmtricitabineClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Zidovudine-Lamivudine
, Zidovudine-Lamivudine
Tradename:CombivirOther Names:ZDV-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Efavirenz-Tenofovir DF-Emtricitabine
Efavirenz-Tenofovir DF-Emtricitabine
Tradename:AtriplaOther Names:EFV-TDF-FTC, Efavirenz-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet RegimensCategories 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.
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
, Abacavir-Lamivudine
Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Tenofovir DF-Emtricitabine
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.
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
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.
- 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.
- 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.
- 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.
- 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.
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
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.
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
, Tenofovir DF
Tradename:VireadOther Names:TDF, tenofovir disoproxil fumarateClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Tenofovir DF-Emtricitabine
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.
- 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.
- Moodley J, Naidoo S, Moodley J, Ramjee G. Sharing of Investigational Drug Among Participants in the Voice Trial. AIDS Behav. 2016;20:2709-2714.
- 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.
- 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.