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Common TitleACTG 5116 (and ACTG 5125s)
Official Title A Randomized, Controlled Trial of Two Potent, Simplified Regimens Utilizing A Protease Inhibitor-Sparing Regimen Versus A Nucleoside-Sparing Regimen for HIV-Infected Subjects Who Participated in ACTG 388 or Who Responded to A First Potent Combination Regimen and Have 200 or Less HIV-1 RNA Copies/ml
Phase Phase III
ClinicalTrials.gov NCT00014937
Treatments
Lopinavir-Ritonavir
Lopinavir-Ritonavir Kaletra

Lopinavir-Ritonavir

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

Efavirenz

Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)
Categories Treatment-ExperiencedSwitch/SimplificationDual TherapyPharmacologyAdverse Effects
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
  • Fischl MA, Collier AC, Mukherjee AL, et al. Randomized open-label trial of two simplified, class-sparing regimens following a first suppressive three or four-drug regimen. AIDS. 2007;21:325-33.
    [PubMed Abstract]
  • Tebas P, Zhang J, Yarasheski K, et al. Switching to a protease inhibitor-containing, nucleoside-sparing regimen (lopinavir/ritonavir plus efavirenz) increases limb fat but raises serum lipid levels: results of a prospective randomized trial (AIDS clinical trial group 5125s). J Acquir Immune Defic Syndr. 2007;45:193-200.
    [PubMed Abstract]

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