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Common TitleACTG 5110 Non-Industry
Official Title A Restrictively Randomized, Open-Label, Controlled, Pilot Study of the Effect of a Thymidine Analogue Substitution or Change to a Nucleoside-Sparing Regimen on Peripheral Fat Wasting
ClinicalTrials.gov NCT00028314
Treatments
Abacavir
Abacavir
Tradename:ZiagenOther Names:ABCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Tebas P, Zhang J, Hafner R, et al. Peripheral and visceral fat changes following a treatment switch to a non-thymidine analogue or a nucleoside-sparing regimen in HIV-infected subjects with peripheral lipoatrophy: results of ACTG A5110. J Antimicrob Chemother. 2009;63:998-1005.
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.
Common TitlePREDICT-1 Industry
Official Title A Phase IV, Randomised, Multicentre, Double-blind, Study to Evaluate the Clinical Utility of Prospective Genetic Screening (HLA-B*5701) for Susceptibility to Abacavir Hypersensitivity
Phase Phase IIIA
ClinicalTrials.gov NCT00340080
Treatments
Abacavir
Abacavir
Tradename:ZiagenOther Names:ABCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PharmacologyTreatment-NaiveTreatment-ExperiencedAdverse Effects
Funding
IndustryGlaxoSmithKline
References
- Mallal S, Phillips E, Carosi G, et al; PREDICT-1 Study Team. HLA-B*5701 screening for hypersensitivity to abacavir. N Engl J Med. 2008;358:568-79.
Common TitleRAVE Industry
Official Title A Phase II, Open-Label, Multicentre, Randomised, Comparator Study of Substitution With Tenofovir or Abacavir in HIV-1 Infected Individuals, With a Viral Load < 50 Copies/mL, Receiving a Thymidine Analogue (Zidovudine or Stavudine) as Part of Their Highly Active Antiretroviral Therapy (HAART)
Phase Phase II
ClinicalTrials.gov NCT00647946
Treatments
Abacavir
, Abacavir
Tradename:ZiagenOther Names:ABCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Tenofovir DF
Tenofovir DF
Tradename:VireadOther Names:TDF, tenofovir disoproxil fumarateClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects
Funding
IndustryGilead Sciences
References
- Moyle GJ, Sabin CA, Cartledge J, et al. A randomized comparative trial of tenofovir DF or abacavir as replacement for a thymidine analogue in persons with lipoatrophy. AIDS. 2006;20:2043-50.
Common TitleTARHEEL Industry
Official Title Glaxo Wellcome Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL)
Phase Phase IV
ClinicalTrials.gov NCT00005764
Treatments
Abacavir
Abacavir
Tradename:ZiagenOther Names:ABCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PharmacologyTreatment-ExperiencedAdverse EffectsSwitch/Simplification
Funding
IndustryGlaxo Wellcome
References
- Lonergan JT, McComsey GA, Fisher RL, et al. Lack of Recurrence of hyperlactatemia in HIV-Infected patients switched from stavudine to abacavir or zidovudine. J Acquir Immune Defic Syndr. 2004;36:935-42.
- McComsey GA, Ward DJ, Hessenthaler SM, et al. Improvement in lipoatrophy associated with highly active antiretroviral therapy in human immunodeficiency virus-infected patients switched from stavudine to abacavir or zidovudine: the results of the TARHEEL study. Clin Infect Dis. 2004;38:263-70.