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
Enfuvirtide Fuzeon
Fostemsavir Rukobia
Ibalizumab Trogarzo
Maraviroc Selzentry
Dolutegravir Tivicay
Raltegravir Isentress
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
Nevirapine Viramune
Rilpivirine Edurant
Atazanavir Reyataz
Atazanavir-Cobicistat Evotaz
Darunavir-Cobicistat Prezcobix
Fosamprenavir Lexiva
Indinavir Crixivan
Lopinavir-Ritonavir Kaletra
Nelfinavir Viracept
Saquinavir Invirase
Tipranavir Aptivus
Cobicistat Tybost
Ritonavir NorvirAll Clinical Trials
Filter by Category
- 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
Official Title Antiretroviral Activity and Tolerability of Once Daily Etravirine in Treatment-Naïve Adults With HIV-1 Infection
Phase Phase II
ClinicalTrials.gov NCT00959894
Treatments
Etravirine
Etravirine
Tradename:IntelenceOther Names:ETRClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Treatment-Naive
Funding
IndustryJanssen
References
- Floris-Moore MA, Mollan K, Wilkin AM, et al. Antiretroviral activity and safety of once-daily etravirine in treatment-naive HIV-infected adults: 48-week results. Antivir Ther. 2016;21:55-64.
Official Title A Phase III Study to Investigate the Efficacy, Tolerability and Safety of Etravirine (TMC-125) as Part of an Antiretroviral Regimen, Including Darunavir/Ritonavir (TMC114/RTV) and an Investigator-selected Optimized Background, in HIV-1 Infected Patients With Limited to no Treatment Options.
Phase Phase III
ClinicalTrials.gov NCT00254046
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Etravirine
Etravirine
Tradename:IntelenceOther Names:ETRClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Resistance/Virological FailureTreatment-ExperiencedAdverse Effects
Funding
IndustryTibotec Pharmaceuticals, Ireland
References
- Anderson D, DeMasi R, DeLaitsch L, Surles T, Coate B. Week 96 outcomes of patients with less treatment experience versus more treatment experience receiving etravirine in the DUET trials. Curr HIV Res. 2012;10:256-61.
- Clotet B, Clumeck N, Katlama C, Nijs S, Witek J. Safety of etravirine in HIV-1/hepatitis B and/or C virus co-infected patients: pooled 96 week results from the Phase III DUET trials. J Antimicrob Chemother. 2010;65:2450-4.
- Girard PM, Campbell TB, Grinsztejn B, et al. Pooled week 96 results of the phase III DUET-1 and DUET-2 trials of etravirine: further analysis of adverse events and laboratory abnormalities of special interest. HIV Med. 2012;13:427-35.
- Katlama C, Clotet B, Mills A, et al. Efficacy and safety of etravirine at week 96 in treatment-experienced HIV type-1-infected patients in the DUET-1 and DUET-2 trials. Antivir Ther. 2010;15:1045-52.
- Katlama C, Haubrich R, Lalezari J, et al. Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials. AIDS. 2009;23:2289-300.
- Madruga JV, Cahn P, Grinsztejn B, et al. Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial. Lancet. 2007;370:29-38.
- Peeters M, Vingerhoets J, Tambuyzer L, et al. Etravirine limits the emergence of darunavir and other protease inhibitor resistance-associated mutations in the DUET trials. AIDS. 2010;24:921-4.
- Tambuyzer L, Vingerhoets J, Azijn H, et al. Characterization of genotypic and phenotypic changes in HIV-1-infected patients with virologic failure on an etravirine-containing regimen in the DUET-1 and DUET-2 clinical studies. AIDS Res Hum Retroviruses. 2010;26:1197-205.
Official Title A Phase III Randomized, Double-blinded, Placebo-controlled Trial to Investigate the Efficacy, Tolerability and Safety of Etravirine (TMC125) as Part of an ART Regimen, Including Darunavir/Ritonavir (TMC114/RTV) and an Investigator-selected OBR, in HIV-1 Infected Patients With Limited Treatment to no Treatment Options.
Phase Phase III
ClinicalTrials.gov NCT00255099
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Etravirine
Etravirine
Tradename:IntelenceOther Names:ETRClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Resistance/Virological FailureTreatment-ExperiencedAdverse Effects
Funding
IndustryTibotec Pharmaceuticals, Ireland
References
- Anderson D, DeMasi R, DeLaitsch L, Surles T, Coate B. Week 96 outcomes of patients with less treatment experience versus more treatment experience receiving etravirine in the DUET trials. Curr HIV Res. 2012;10:256-61.
- Clotet B, Clumeck N, Katlama C, Nijs S, Witek J. Safety of etravirine in HIV-1/hepatitis B and/or C virus co-infected patients: pooled 96 week results from the Phase III DUET trials. J Antimicrob Chemother. 2010;65:2450-4.
- Girard PM, Campbell TB, Grinsztejn B, et al. Pooled week 96 results of the phase III DUET-1 and DUET-2 trials of etravirine: further analysis of adverse events and laboratory abnormalities of special interest. HIV Med. 2012;13:427-35.
- Katlama C, Clotet B, Mills A, et al. Efficacy and safety of etravirine at week 96 in treatment-experienced HIV type-1-infected patients in the DUET-1 and DUET-2 trials. Antivir Ther. 2010;15:1045-52.
- Katlama C, Haubrich R, Lalezari J, et al. Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials. AIDS. 2009;23:2289-300.
- Lazzarin A, Campbell T, Clotet B, et al. Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-2: 24-week results from a randomised, double-blind, placebo-controlled trial. Lancet. 2007;370:39-48.
- Peeters M, Vingerhoets J, Tambuyzer L, et al. Etravirine limits the emergence of darunavir and other protease inhibitor resistance-associated mutations in the DUET trials. AIDS. 2010;24:921-4.
- Tambuyzer L, Vingerhoets J, Azijn H, et al. Characterization of genotypic and phenotypic changes in HIV-1-infected patients with virologic failure on an etravirine-containing regimen in the DUET-1 and DUET-2 clinical studies. AIDS Res Hum Retroviruses. 2010;26:1197-205.
Official Title Pilot Study to Assess the Efficacy and Safety of Switching Protease Inhibitor to Etravirine in HIV-1-infected Subjects With Viremia Suppression
Phase Phase III
ClinicalTrials.gov NCT01034917
Treatments
Etravirine
Etravirine
Tradename:IntelenceOther Names:ETRClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects
Funding
Non-IndustrySpanish AIDS Network
References
- Echeverría P, Bonjoch A, Puig J, et al. Randomised study to assess the efficacy and safety of once-daily etravirine-based regimen as a switching strategy in HIV-infected patients receiving a protease inhibitor-containing regimen. Etraswitch study. PLoS One. 2014;9:e84676.
Official Title A Multicenter, Single Arm, Open-Label Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients
Phase Phase II
ClinicalTrials.gov NCT01199939
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Etravirine
Etravirine
Tradename:IntelenceOther Names:ETRClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Resistance/Virological FailureTreatment-NaiveTreatment-ExperiencedDual Therapy
Funding
IndustryJanssen
References
- Ruane PJ, Brinson C, Ramgopal M, et al. The Intelence aNd pRezista Once A Day Study (INROADS): a multicentre, single-arm, open-label study of etravirine and darunavir/ritonavir as dual therapy in HIV-1-infected early treatment-experienced subjects. HIV Med. 2015;16:288-96.
Official Title A Phase II, Open-label Trial, to Evaluate the Safety, Tolerability and Antiviral Activity of Etravirine (TMC125) in Antiretroviral Experienced HIV-1 Infected Children and Adolescents
Phase Phase II
ClinicalTrials.gov NCT00665847
Treatments
Etravirine
Etravirine
Tradename:IntelenceOther Names:ETRClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Resistance/Virological FailurePediatricsTreatment-Experienced
Funding
IndustryTibotec Pharmaceuticals
References
- Tambuyzer L, Thys K, Hoogstoel A, et al. Assessment of etravirine resistance in HIV-1-infected paediatric patients using population and deep sequencing: final results of the PIANO study. Antivir Ther. 2016;21:317-27.
- Tudor-Williams G, Cahn P, Chokephaibulkit K, et al. Etravirine in treatment-experienced, HIV-1-infected children and adolescents: 48-week safety, efficacy and resistance analysis of the phase II PIANO study. HIV Med. 2014;15:513-24.
Official Title A Phase IIb, Multi-centre, Randomised, Double-blind, Active-controlled Trial Comparing the Neuropsychiatric Adverse Event Profile of Etravirine 400mg qd Versus Efavirenz 600mg qd in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in ARV Therapy-naive HIV-1 Infected Subjects
Phase Phase IIB
ClinicalTrials.gov NCT00903682
Treatments
Etravirine
Etravirine
Tradename:IntelenceOther Names:ETRClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories PharmacologyTreatment-NaiveAdverse Effects
Funding
IndustryJanssen-Cilag
References
- Fätkenheuer G, Duvivier C, Rieger A, et al. Lipid profiles for etravirine versus efavirenz in treatment-naive patients in the randomized, double-blind SENSE trial. J Antimicrob Chemother. 2012;67:685-90.
- Gazzard B, Duvivier C, Zagler C, et al. Phase 2 double-blind, randomized trial of etravirine versus efavirenz in treatment-naive patients: 48-week results. AIDS. 2011;25:2249-58.
- Nelson M, Stellbrink HJ, Podzamczer D, et al. A comparison of neuropsychiatric adverse events during 12 weeks of treatment with etravirine and efavirenz in a treatment-naive, HIV-1-infected population. AIDS. 2011;25:335-40.
Official Title A Phase III, Double Blind, Multi-centre, Randomised Placebo Controlled, Pilot Study to Assess the Feasibility of Switching Individuals Receiving Efavirenz With Continuing Central Nervous System (CNS) Toxicity to Etravirine (TMC125).
Phase Phase IV
ClinicalTrials.gov NCT00792324
Treatments
Etravirine
Etravirine
Tradename:IntelenceOther Names:ETRClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects
Funding
IndustryTibotec Pharmaceuticals
References
- Waters L, Fisher M, Winston A, et al. A phase IV, double-blind, multicentre, randomized, placebo-controlled, pilot study to assess the feasibility of switching individuals receiving efavirenz with continuing central nervous system adverse events to etravirine. AIDS. 2011;25:65-71.
Official Title Patient Preference, Sleep Quality, and Anxiety/Depression: A Randomized Comparison of Etravirine and Efavirenz
ClinicalTrials.gov NCT00792584
Treatments
Etravirine
Etravirine
Tradename:IntelenceOther Names:ETRClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects
Funding
IndustryTibotec Pharmaceuticals
References
- Nguyen A, Calmy A, Delhumeau C, et al. A randomized crossover study to compare efavirenz and etravirine treatment. AIDS. 2011;25:57-63.
Official Title A Randomized, Controlled, Partially Blinded Phase IIb Dose-Finding Trial of Etravirine (TMC125) in HIV-1 Infected Subjects With Documented Genotypic Evidence of Resistance to Currently Available NNRTIs and With at Least Three Primary PI Mutations
Phase Phase IIB
ClinicalTrials.gov NCT00081978
Treatments
Etravirine
Etravirine
Tradename:IntelenceOther Names:ETRClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Resistance/Virological FailureTreatment-Experienced
Funding
IndustryTibotec Pharmaceuticals, Ireland
References
- Cohen CJ, Berger DS, Blick G, et al. Efficacy and safety of etravirine (TMC125) in treatment-experienced HIV-1-infected patients: 48-week results of a phase IIb trial. AIDS. 2009;23:423-6.
- TMC125-C223 Writing Group, Nadler JP, Berger DS, et al. Efficacy and safety of etravirine (TMC125) in patients with highly resistant HIV-1: primary 24-week analysis. AIDS. 2007;21:F1-10.
Official Title A Phase II, Randomized, Active Controlled, Open Label Trial to Investigate the Efficacy and Tolerability of Etravirine (TMC125) in HIV-1 Infected Subjects, Who Are PI-naive and With Documented Genotypic Evidence of NNRTI Resistance From Previous NNRTI Use.
Phase Phase II
ClinicalTrials.gov NCT00225303
Treatments
Etravirine
Etravirine
Tradename:IntelenceOther Names:ETRClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Treatment-Experienced
Funding
IndustryTibotec Pharmaceuticals, Ireland
References
- Ruxrungtham K, Pedro RJ, Latiff GH, et al. Impact of reverse transcriptase resistance on the efficacy of TMC125 (etravirine) with two nucleoside reverse transcriptase inhibitors in protease inhibitor-naïve, nonnucleoside reverse transcriptase inhibitor-experienced patients: study TMC125-C227. HIV Med. 2008;9:883-96.
Official Title Prospective Clinical Trial to Assess Safety and Efficacy of Darunavir/ritonavir (TMC 114/r), Etravirine (TMC 125) and Raltegravir (MK-0518) in Addition to OBT in HIV-1 Infected Patients With Limited to No Treatment Options ANRS 139 TRIO
Phase Phase II
ClinicalTrials.gov NCT00460382
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Etravirine
Etravirine
Tradename:IntelenceOther Names:ETRClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Resistance/Virological FailureTreatment-Experienced
Funding
IndustryMerck Sharp & Dohme Corp; Janssen
Non-IndustryFrench National Agency for Research on AIDS and Viral Hepatitis
References
- Charpentier C, Fagard C, Colin C, et al. Role of baseline HIV-1 DNA level in highly-experienced patients receiving raltegravir, etravirine and darunavir/ritonavir regimen (ANRS139 TRIO trial). PLoS One. 2013;8:e53621.
- Charpentier C, Lee GQ, Rodriguez C, et al. Highly frequent HIV-1 minority resistant variants at baseline of the ANRS 139 TRIO trial had a limited impact on virological response. J Antimicrob Chemother. 2015;70:2090-6.
- Charpentier C, Roquebert B, Colin C, et al. Resistance analyses in highly experienced patients failing raltegravir, etravirine and darunavir/ritonavir regimen. AIDS. 2010;24:2651-6.
- Fagard C, Colin C, Charpentier C, et al. Long-term efficacy and safety of raltegravir, etravirine, and darunavir/ritonavir in treatment-experienced patients: week 96 results from the ANRS 139 TRIO trial. J Acquir Immune Defic Syndr. 2012;59:489-93.
- Yazdanpanah Y, Fagard C, Descamps D, et al. High rate of virologic suppression with raltegravir plus etravirine and darunavir/ritonavir among treatment-experienced patients infected with multidrug-resistant HIV: results of the ANRS 139 TRIO trial. Clin Infect Dis. 2009;49:1441-9.