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
Efavirenz-Tenofovir DF-Emtricitabine Atripla
Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine Genvoya
Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine Stribild
Rilpivirine-Tenofovir alafenamide-Emtricitabine Odefsey
Rilpivirine-Tenofovir DF-Emtricitabine Complera
Fostemsavir Rukobia
Ibalizumab Trogarzo
Maraviroc Selzentry
Dolutegravir Tivicay
Abacavir Ziagen
Abacavir-Lamivudine Epzicom
Abacavir-Lamivudine-Zidovudine Trizivir
Didanosine Videx
Emtricitabine Emtriva
Lamivudine Epivir
Stavudine Zerit
Tenofovir alafenamide-Emtricitabine Descovy
Tenofovir DF Viread
Tenofovir DF-Emtricitabine Truvada and Multiple Generics
Zidovudine Retrovir
Zidovudine-Lamivudine Combivir
Doravirine Pifeltro
Efavirenz Sustiva
Etravirine Intelence
Nevirapine Viramune
Rilpivirine Edurant
Atazanavir Reyataz
Atazanavir-Cobicistat Evotaz
Darunavir Prezista
Darunavir-Cobicistat Prezcobix
Fosamprenavir Lexiva
Indinavir Crixivan
Lopinavir-Ritonavir Kaletra
Nelfinavir Viracept
Saquinavir Invirase
Tipranavir Aptivus
Cobicistat Tybost
Ritonavir NorvirAll Clinical Trials
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Official Title A Pilot Study to Measure the Clearance of Replication-Competent HIV-1 in Resting Memory CD4+ Cells in HIV-1-Infected Subjects Who Receive Enfuvirtide Plus Oral Combination Antiretroviral Therapy
ClinicalTrials.gov NCT00051831
Treatments
Enfuvirtide
Enfuvirtide
Tradename:FuzeonOther Names:T-20Class:Entry InhibitorsCategories Treatment-Naive
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Gandhi RT, Bosch RJ, Aga E, et al. No evidence for decay of the latent reservoir in HIV-1-infected patients receiving intensive enfuvirtide-containing antiretroviral therapy. J Infect Dis. 2010;201:293-6.
Official Title Enfuvirtide for the Initial Phase of Antiretroviral Therapy in HIV-infected Patients With High Risk of Clinical Progression : ANRS 130 APOLLO
Phase Phase III
ClinicalTrials.gov NCT00302822
Treatments
Enfuvirtide
Enfuvirtide
Tradename:FuzeonOther Names:T-20Class:Entry InhibitorsCategories Treatment-Naive
Funding
Non-IndustryFrench National Agency for Research on AIDS and Viral Hepatitis
References
- Charpentier C, Joly V, Larrouy L, et al. Role and evolution of viral tropism in patients with advanced HIV disease receiving intensified initial regimen in the ANRS 130 APOLLO trial. J Antimicrob Chemother. 2013;68:690-6.
- Joly V, Fagard C, Grondin C, et al. Intensification of antiretroviral therapy through addition of enfuvirtide in naive HIV-1-infected patients with severe immunosuppression does not improve immunological response: results of a randomized multicenter trial (ANRS 130 Apollo). Antimicrob Agents Chemother. 2013;57:758-65.
Official Title A Multicenter, Open-label Study Evaluating the Safety and Efficacy of a New Protease Inhibitor (Darunavir) With Fuzeon® (Enfuvirtide) Plus Background Antiretroviral Regimen in HIV-1 Infected, Triple-class Treatment-experienced Patients
Phase Phase IV
ClinicalTrials.gov NCT00326963
Treatments
Enfuvirtide
Enfuvirtide
Tradename:FuzeonOther Names:T-20Class:Entry InhibitorsCategories Resistance/Virological FailureTreatment-Experienced
Funding
IndustryHoffmann-La Roche
References
- DeJesus E, Gottlieb MS, Gathe JC Jr, Greenberg ML, Guittari CJ, Zolopa AR. Safety and efficacy of enfuvirtide in combination with darunavir-ritonavir and an optimized background regimen in treatment-experienced human immunodeficiency virus-infected patients: the below the level of quantification study. Antimicrob Agents Chemother. 2008;52:4315-9.
Official Title Biojector 2000 Open-Label Safety Study (BOSS) to Evaluate Signs and Symptoms Associated With a Needle-free Injection Device for Administration of Fuzeon to Patients With HIV-1 Infection
Phase Phase IV
ClinicalTrials.gov NCT00337701
Treatments
Enfuvirtide
Enfuvirtide
Tradename:FuzeonOther Names:T-20Class:Entry InhibitorsCategories PharmacologyTreatment-ExperiencedAdverse Effects
Funding
IndustryHoffmann-La Roche
References
- Lalezari JP, Saag M, Walworth C, Larson P. An open-label safety study of enfuvirtide injection with a needle-free injection device or needle/syringe: the Biojector 2000 Open-label Safety Study (BOSS). AIDS Res Hum Retroviruses. 2008;24:805-13.
Official Title Virologic Outcomes of Changing Enfuvirtide to Raltegravir in HIV-1 Patients Well Controlled on an Enfuvirtide Based Regimen
Phase Phase III
ClinicalTrials.gov NCT00529243
Treatments
Raltegravir
, Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Enfuvirtide
Enfuvirtide
Tradename:FuzeonOther Names:T-20Class:Entry InhibitorsCategories Treatment-ExperiencedSwitch/Simplification
Funding
Non-IndustryKaiser Permanente
References
- Towner W, Klein D, Kerrigan HL, Follansbee S, Yu K, Horberg M. Virologic outcomes of changing enfuvirtide to raltegravir in HIV-1 patients well controlled on an enfuvirtide based regimen: 24-week results of the CHEER study. J Acquir Immune Defic Syndr. 2009;51:367-73.
Official Title Randomized Non-inferiority Study Comparing a Strategy Maintaining Current Enfuvirtide-based Antiretroviral Therapy to a Strategy Replacing Enfuvirtide by an Integrase Inhibitor (Raltegravir) in HIV-1 Infected Subjects With Plasma Hiv-1 RNA Levels Below 400 Copies Per ml.ANRS 138 EASIER
Phase Phase III
ClinicalTrials.gov NCT00454337.
Treatments
Raltegravir
, Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Enfuvirtide
Enfuvirtide
Tradename:FuzeonOther Names:T-20Class:Entry InhibitorsCategories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects
Funding
Non-IndustryFrench National Agency for Research on AIDS and Viral Hepatitis
References
- de Castro N, Braun J, Charreau I, et al. Incidence and risk factors for liver enzymes elevations in highly treatment-experienced patients switching from enfuvirtide to raltegravir: a sub-study of the ANRS-138 EASIER trial. AIDS Res Ther. 2016;13:17.
- De Castro N, Braun J, Charreau I, et al. Switch from enfuvirtide to raltegravir in virologically suppressed multidrug-resistant HIV-1-infected patients: a randomized open-label trial. Clin Infect Dis. 2009;49:1259-67.
- Gallien S, Braun J, Delaugerre C, et al. Efficacy and safety of raltegravir in treatment-experienced HIV-1-infected patients switching from enfuvirtide-based regimens: 48 week results of the randomized EASIER ANRS 138 trial. J Antimicrob Chemother. 2011;66:2099-106.
Official Title Study of the Immunological Efficacy of Adding Subcutaneous Interleukin-2 (IL-2) to an Optimized Antiretroviral Regimen in HIV-1-infected Subjects Experiencing Therapeutic Failure on an Ongoing Antiretroviral Combination With a CD4 Cell Count ≤ 200/mm3 ANRS 123 Trial
Phase Phase II
ClinicalTrials.gov NCT00113282
Treatments
Enfuvirtide
Enfuvirtide
Tradename:FuzeonOther Names:T-20Class:Entry InhibitorsCategories Resistance/Virological FailureTreatment-Experienced
Funding
Non-IndustryFrench National Agency for Research on AIDS and Viral Hepatitis
References
- Viard JP, Fagard C, Chaix ML, et al. Immunological success is predicted by enfuvirtide but not interleukin-2 therapy in immunodepressed patients. AIDS. 2009;23:1383-8.
Official Title A Randomized, Open-label Study Evaluating the Antiviral Activity and Safety of 3 Month Fuzeon Induction With an Optimized Background Antiretroviral Regimen Versus OB Alone, in Fuzeon-naive HIV-1 Infected Patients With Virological Failure.
Phase Phase II
ClinicalTrials.gov NCT00615134
Treatments
Enfuvirtide
Enfuvirtide
Tradename:FuzeonOther Names:T-20Class:Entry InhibitorsCategories Resistance/Virological FailureTreatment-Experienced
Funding
IndustryHoffmann-La Roche
References
- Morand-Joubert L, Ghosn J, Delaugerre C, et al. Lack of benefit of 3-month intensification with enfuvirtide plus optimized background regimen (OBR) versus OBR alone in patients with multiple therapeutic failures: the INNOVE study. J Med Virol. 2012;84:1710-8.
Official Title Phase IIIb/IV Randomized, Controlled Study Evaluating an Intensification Treatment Strategy of Adding Enfuvirtide (ENF) to an Oral Highly Active AntiRetroviral Therapy (HAART) in Treatment Experienced Patients
Phase Phase IV
ClinicalTrials.gov NCT00487188
Treatments
Enfuvirtide
Enfuvirtide
Tradename:FuzeonOther Names:T-20Class:Entry InhibitorsCategories Resistance/Virological FailureTreatment-Experienced
Funding
IndustryHoffmann-La Roche
References
- Clotet B, Capetti A, Soto-Ramirez LE, et al. A randomized, controlled study evaluating an induction treatment strategy in which enfuvirtide was added to an oral, highly active antiretroviral therapy regimen in treatment-experienced patients: the INTENSE study. J Antimicrob Chemother. 2008;62:1374-8.
Official Title A Phase I/II Study of T-20, a Fusion Inhibitor, in HIV-1 Infected Children
Phase Phase I
ClinicalTrials.gov NCT00001118
Treatments
Enfuvirtide
Enfuvirtide
Tradename:FuzeonOther Names:T-20Class:Entry InhibitorsCategories Resistance/Virological FailurePediatricsTreatment-Experienced
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Church JA, Cunningham C, Hughes M, et al. Safety and antiretroviral activity of chronic subcutaneous administration of T-20 in human immunodeficiency virus 1-infected children. Pediatr Infect Dis J. 2002;21:653-9.
- Church JA, Hughes M, Chen J, et al. Long term tolerability and safety of enfuvirtide for human immunodeficiency virus 1-infected children. Pediatr Infect Dis J. 2004;23:713-8.
- Soy D, Aweeka FT, Church JA, et al. Population pharmacokinetics of enfuvirtide in pediatric patients with human immunodeficiency virus: searching for exposure-response relationships. Clin Pharmacol Ther. 2003;74:569-80.
Official Title A Controlled Phase 2 Trial Assessing Three Doses of T-20 in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz in HIV-1 Infected Adults
Phase Phase II
ClinicalTrials.gov NCT00002239
Treatments
Enfuvirtide
Enfuvirtide
Tradename:FuzeonOther Names:T-20Class:Entry InhibitorsCategories PharmacologyTreatment-ExperiencedGeneral Pharmacology
Funding
IndustryHoffmann-La Roche
References
- Lalezari JP, DeJesus E, Northfelt DW, et al. A controlled Phase II trial assessing three doses of enfuvirtide (T-20) in combination with abacavir, amprenavir, ritonavir and efavirenz in non-nucleoside reverse transcriptase inhibitor-naive HIV-infected adults. Antivir Ther. 2003;8:279-87.
Official Title A Phase II Open-label, Randomized, Active-controlled Study Comparing the Efficacy and Safety of Once Daily Enfuvirtide Dosing Versus the Currently Recommended Twice Daily Dosing in HIV-1 Infected Treatment-experienced Patients.
Phase Phase II
ClinicalTrials.gov NCT00089492
Treatments
Enfuvirtide
Enfuvirtide
Tradename:FuzeonOther Names:T-20Class:Entry InhibitorsCategories PharmacologyTreatment-ExperiencedGeneral Pharmacology
Funding
IndustryHoffmann-La Roche
References
- Wright D, Rodriguez A, Godofsky E, et al. Efficacy and safety of 48 weeks of enfuvirtide 180 mg once-daily dosing versus 90 mg twice-daily dosing in HIV-infected patients. HIV Clin Trials. 2008;9:73-82.
Common TitleTORO 1 Industry
Official Title A Phase III Open-Label, Randomized, Active-Controlled Study Assessing the Efficacy and Safety of T-20 (HIV-1 Fusion Inhibitor) in Combination With an Optimized Background Regimen, Versus Optimized Background Therapy Alone, in Patients With Prior Experience and/or Prior Documented Resistance to Each of the Three Classes of Approved Antiretrovirals (Nucleoside Reverse Transcriptase, Non-Nucleoside Reverse Transcriptase and Protease Inhibitors)
Phase Phase III
ClinicalTrials.gov NCT00008528
Treatments
Enfuvirtide
Enfuvirtide
Tradename:FuzeonOther Names:T-20Class:Entry InhibitorsCategories Resistance/Virological FailureTreatment-ExperiencedPharmacologyAdverse Effects
Funding
IndustryHoffmann-La Roche
References
- Cohen CJ, Clumeck N, Molina JM, et al. Health-related quality of life with enfuvirtide (ENF; T-20) in combination with an optimized background regimen. J Acquir Immune Defic Syndr. 2004;37:1140-6.
- Cooper DA, Cordery DV, Reiss P, et al. The effects of enfuvirtide therapy on body composition and metabolic parameters over 48 weeks in the TORO body imaging substudy. HIV Med. 2011;12:31-9.
- Lalezari JP, Henry K, O'Hearn M, et al. Enfuvirtide, an HIV-1 fusion inhibitor, for drug-resistant HIV infection in North and South America. N Engl J Med. 2003;348:2175-85.
- Melby T, Sista P, DeMasi R, et al. Characterization of envelope glycoprotein gp41 genotype and phenotypic susceptibility to enfuvirtide at baseline and on treatment in the phase III clinical trials TORO-1 and TORO-2. AIDS Res Hum Retroviruses. 2006;22:375-85.
- Melby TE, Despirito M, Demasi RA, et al. Association between specific enfuvirtide resistance mutations and CD4 cell response during enfuvirtide-based therapy. AIDS. 2007;21:2537-9.
- Nelson M, Arastéh K, Clotet B, et al. Durable efficacy of enfuvirtide over 48 weeks in heavily treatment-experienced HIV-1-infected patients in the T-20 versus optimized background regimen only 1 and 2 clinical trials. J Acquir Immune Defic Syndr. 2005;40:404-12.
- Raffi F, Katlama C, Saag M, et al. Week-12 response to therapy as a predictor of week 24, 48, and 96 outcome in patients receiving the HIV fusion inhibitor enfuvirtide in the T-20 versus Optimized Regimen Only (TORO) trials. Clin Infect Dis. 2006;42:870-7.
- Reynes J, Arastéh K, Clotet B, et al. TORO: ninety-six-week virologic and immunologic response and safety evaluation of enfuvirtide with an optimized background of antiretrovirals. AIDS Patient Care STDS. 2007;21:533-43.
- Rockstroh J, Dejesus E, Donatacci L, et al. Adherence to enfuvirtide and its impact on treatment efficacy. AIDS Res Hum Retroviruses. 2008;24:141-8.
- Sax PE, Losina E, Weinstein MC, et al. Cost-effectiveness of enfuvirtide in treatment-experienced patients with advanced HIV disease. J Acquir Immune Defic Syndr. 2005;39:69-77.
- Trottier B, Walmsley S, Reynes J, et al. Safety of enfuvirtide in combination with an optimized background of antiretrovirals in treatment-experienced HIV-1-infected adults over 48 weeks. J Acquir Immune Defic Syndr. 2005;40:413-21.
- Walmsley S, Henry K, Katlama C, et al. Enfuvirtide (T-20) cross-reactive glycoprotein 41 antibody does not impair the efficacy or safety of enfuvirtide. J Infect Dis. 2003;188:1827-33.
Common TitleTORO-2 Industry
Official Title A Phase III Open-Label, Randomized, Active-Controlled Study Assessing the Efficacy and Safety of T-20 (HIV-1 Fusion Inhibitor) in Combination With an Optimized Background Regimen, Versus Optimized Background Regimen Alone, in Patients With Prior Experience and/or Prior Documented Resistance to Each of the Three Classes of Approved Antiretrovirals (Nucleoside Reverse Transcriptase, Non-Nucleoside Reverse Transcriptase and Protease Inhibitors)
Phase Phase III
ClinicalTrials.gov NCT00021554
Treatments
Enfuvirtide
Enfuvirtide
Tradename:FuzeonOther Names:T-20Class:Entry InhibitorsCategories Resistance/Virological FailureTreatment-ExperiencedPharmacologyAdverse Effects
Funding
IndustryHoffmann-La Roche
References
- Cohen CJ, Clumeck N, Molina JM, et al. Health-related quality of life with enfuvirtide (ENF; T-20) in combination with an optimized background regimen. J Acquir Immune Defic Syndr. 2004;37:1140-6.
- Cooper DA, Cordery DV, Reiss P, et al. The effects of enfuvirtide therapy on body composition and metabolic parameters over 48 weeks in the TORO body imaging substudy. HIV Med. 2011;12:31-9.
- Lazzarin A, Clotet B, Cooper D, et al. Efficacy of enfuvirtide in patients infected with drug-resistant HIV-1 in Europe and Australia. N Engl J Med. 2003;348:2186-95.
- Melby T, Sista P, DeMasi R, et al. Characterization of envelope glycoprotein gp41 genotype and phenotypic susceptibility to enfuvirtide at baseline and on treatment in the phase III clinical trials TORO-1 and TORO-2. AIDS Res Hum Retroviruses. 2006;22:375-85.
- Melby TE, Despirito M, Demasi RA, et al. Association between specific enfuvirtide resistance mutations and CD4 cell response during enfuvirtide-based therapy. AIDS. 2007;21:2537-9.
- Nelson M, Arastéh K, Clotet B, et al. Durable efficacy of enfuvirtide over 48 weeks in heavily treatment-experienced HIV-1-infected patients in the T-20 versus optimized background regimen only 1 and 2 clinical trials. J Acquir Immune Defic Syndr. 2005;40:404-12.
- Raffi F, Katlama C, Saag M, et al. Week-12 response to therapy as a predictor of week 24, 48, and 96 outcome in patients receiving the HIV fusion inhibitor enfuvirtide in the T-20 versus Optimized Regimen Only (TORO) trials. Clin Infect Dis. 2006;42:870-7.
- Reynes J, Arastéh K, Clotet B, et al. TORO: ninety-six-week virologic and immunologic response and safety evaluation of enfuvirtide with an optimized background of antiretrovirals. AIDS Patient Care STDS. 2007;21:533-43.
- Rockstroh J, Dejesus E, Donatacci L, et al. Adherence to enfuvirtide and its impact on treatment efficacy. AIDS Res Hum Retroviruses. 2008;24:141-8.
- Sax PE, Losina E, Weinstein MC, et al. Cost-effectiveness of enfuvirtide in treatment-experienced patients with advanced HIV disease. J Acquir Immune Defic Syndr. 2005;39:69-77.
- Trottier B, Walmsley S, Reynes J, et al. Safety of enfuvirtide in combination with an optimized background of antiretrovirals in treatment-experienced HIV-1-infected adults over 48 weeks. J Acquir Immune Defic Syndr. 2005;40:413-21.
- Walmsley S, Henry K, Katlama C, et al. Enfuvirtide (T-20) cross-reactive glycoprotein 41 antibody does not impair the efficacy or safety of enfuvirtide. J Infect Dis. 2003;188:1827-33.
Common TitleTRI-003 Industry
Official Title A Phase II Evaluation of the Safety, Plasma Pharmacokinetics, and Antiviral Activity of T-20 Administered to HIV-1 Positive Adults By Continuous Subcutaneous Infusion or Subcutaneous Injection
Phase Phase II
ClinicalTrials.gov NCT00002228
Treatments
Enfuvirtide
Enfuvirtide
Tradename:FuzeonOther Names:T-20Class:Entry InhibitorsCategories PharmacologyTreatment-ExperiencedGeneral Pharmacology
Funding
IndustryTrimeris
References
- Kilby JM, Lalezari JP, Eron JJ, et al. The safety, plasma pharmacokinetics, and antiviral activity of subcutaneous enfuvirtide (T-20), a peptide inhibitor of gp41-mediated virus fusion, in HIV-infected adults. AIDS Res Hum Retroviruses. 2002;18:685-93.
Common TitleWAND Industry
Official Title An Open-label Study of the Tolerability of a Subcutaneous Needle-free Injection Device Used to Administer Fuzeon, Compared With the Standard Needle/Syringe Supplied With Commercial Fuzeon in HIV-1 Infected, ARV Treatment-experienced Adults
Phase Phase IV
ClinicalTrials.gov NCT00233883
Treatments
Enfuvirtide
Enfuvirtide
Tradename:FuzeonOther Names:T-20Class:Entry InhibitorsCategories PharmacologyTreatment-ExperiencedAdverse Effects
Funding
IndustryHoffmann-La Roche
References
- Gottlieb M, Thommes JA. Short communication safety, tolerability and pharmacokinetics of enfuvirtide administered by a needle-free injection system compared with subcutaneous injection. Antivir Ther. 2008;13:723-7.