Common TitleDUET 2
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.