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 Medicine

Volumn 13, Issue 7, 2012, Pages 427-435

  Girard, P M ^a,b   Campbell, Tb ^c   Grinsztejn, B ^d   Hartikainen, J ^e   Rachline, A ^f   Nijs, S ^g   Witek, J ^h  

^a HÔPITAL SAINT ANTOINE   (France)

^b INSERM   (France)

^c UNIVERSITY OF COLORADO   (United States)

^d Funda??o Oswaldo Cruz   (Brazil)

^e Epimed c/o Auguste Viktoria Klinikum   (Germany)

^f SAINT LOUIS HOSPITAL   (France)

^g TIBOTEC BVBA   (Belgium)

^h Tibotec Inc   (United States)

Author keywords

Adverse events; DUET; Etravirine; Safety; Treatment experienced

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CHOLESTEROL; DARUNAVIR PLUS RITONAVIR; ETRAVIRINE; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PLACEBO; TRIACYLGLYCEROL; VIRUS RNA;

ABNORMAL LABORATORY RESULT; ADVERSE OUTCOME; ANXIETY; ARTICLE; CHOLESTEROL BLOOD LEVEL; CONTROLLED STUDY; DEPRESSION; DISEASE DURATION; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; DYSLIPIDEMIA; FEMALE; HEADACHE; HEPATITIS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; INCIDENCE; INSOMNIA; LIVER DISEASE; MAJOR CLINICAL STUDY; MALE; MEDICAL HISTORY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PSYCHOPATHY; RANDOMIZED CONTROLLED TRIAL; RASH; RISK ASSESSMENT; SEX DIFFERENCE; SIDE EFFECT; SOMNOLENCE; TRIACYLGLYCEROL BLOOD LEVEL; VIRUS LOAD;

ACQUIRED IMMUNODEFICIENCY SYNDROME; ADULT; ANTI-HIV AGENTS; DIZZINESS; DOUBLE-BLIND METHOD; EXANTHEMA; FEMALE; HEADACHE; HUMANS; MALE; MIDDLE AGED; MOOD DISORDERS; PYRIDAZINES; SLEEP DISORDERS; VIRAL LOAD;

EID: 84863222366     PISSN: 14642662     EISSN: 14681293     Source Type: Journal    
DOI: 10.1111/j.1468-1293.2012.00994.x     Document Type: Article

References (14)

1. Andries K, Azijn H, Thielemans T etal. TMC125, a novel next-generation non-nucleoside reverse transcriptase inhibitor active against non-nucleoside reverse transcriptase inhibitor-resistant human immunodeficiency virus type 1. Antimicrob Agents Chemother 2004; 48: 4680-4686.
2. Vingerhoets J, Azijn H, Fransen E etal. TMC125 displays a high genetic barrier to the development of resistance: evidence from in-vitro selection experiments. J Virol 2005; 79: 12773-12782.
3. Katlama C, Haubrich R, Lalezari J etal. Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials. AIDS 2009; 23: 2289-2300.
4. Katlama C, Clotet B, Mills A etal. 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: 1045-1052.
5. 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: 2450-2454.
6. Madruga JV, Cahn P, Grinsztejn B etal. 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.
7. Lazzarin A, Campbell T, Clotet B etal. 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.
8. TM (etravirine) prescribing information. December 2010. Available at (accessed 10 May 2011).
9. INTELENCE (etravirine): summary of product characteristics (EMEA). Available at (accessed 10 May 2011).
10. Nelson M, Stellbrink HJ, Podzamczer D etal. 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: 335-340.
11. van Leth F, Phanuphak P, Ruxrungtham K etal. Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomised open-label trial, the 2NN Study. Lancet 2004; 363: 1253-1263.
12. Manfredi R, Calza L, Chiodo F. Prospective, open-label comparative study of liver toxicity in an unselected population of HIV-infected patients treated for the first time with efavirenz or nevirapine. HIV Clin Trials 2005; 6: 302-311.
13. Montaner J, Yeni P, Clumeck NN etal. Safety, tolerability, and preliminary efficacy of 48 weeks of etravirine therapy in a phase IIb dose-ranging study involving treatment-experienced patients with HIV-1 infection. Clin Infect Dis 2008; 47: 969-978.
14. Cohen CJ, Berger DS, Blick G etal. Efficacy and safety of etravirine (TMC125) in treatment-experienced HIV-1-infected patients: 48-week results of a phase IIb trial. AIDS 2009; 23: 423-426.