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

Clinical Infectious Diseases

Volumn 47, Issue 7, 2008, Pages 969-978

  Montaner, Julio ^a   Yeni, Patrick ^b   Clumeck, Nathan N ^c   Fätkenheuer, Gerd ^e   Gatell, Jose ^f   Hay, Phillip ^g   Seminari, Elena ^h   Peeters, Monika P ^d   Schöller Gyüre, Monika ^d   Simonts, Myriam ^d   Woodfall, Brian ^d  

^a UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^b BICHAT HOSPITAL   (France)

^c SAINT PIERRE UNIVERSITY HOSPITAL   (Belgium)

^d TIBOTEC BVBA   (Belgium)

^e UNIVERSITY OF COLOGNE   (Germany)

^f HOSPITAL CLÍNIC   (Spain)

^g ST GEORGE S HOSPITAL   (United Kingdom)

^h VITA SALUTE SAN RAFFAELE UNIVERSITY   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ABACAVIR; EFAVIRENZ; ETRAVIRINE; LOPINAVIR; PLACEBO; RITONAVIR; SAQUINAVIR; TF 035; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ABNORMAL DREAMING; ADULT; AGED; ANXIETY; ARTICLE; BACKACHE; CLINICAL TRIAL; CONNECTIVE TISSUE DISEASE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DEPRESSION; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ERYTHEMA; FATIGUE; FEMALE; FEVER; HEADACHE; HEPATOBILIARY DISEASE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERTRIGLYCERIDEMIA; INJECTION SITE REACTION; INSOMNIA; KIDNEY DISEASE; LIBIDO DISORDER; MACULOPAPULAR RASH; MAJOR CLINICAL STUDY; MALE; MEMORY DISORDER; MENTAL DISEASE; MUSCULOSKELETAL DISEASE; NAUSEA; NEUROLOGIC DISEASE; PANCREATITIS; PAPULAR RASH; PHARYNGITIS; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; RHINOPHARYNGITIS; SIDE EFFECT; SKIN DISEASE; SKIN TOXICITY; SLEEP DISORDER; SOMNOLENCE; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION; URINARY DYSFUNCTION; VIRUS LOAD; VOMITING;

ADULT; AGED; ANTI-HIV AGENTS; CD4 LYMPHOCYTE COUNT; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; MALE; MIDDLE AGED; PYRIDAZINES;

EID: 52449097524     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/591705     Document Type: Article

References (23)

1. US Department of Health and Human Services. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. 29 January 2008. Available at: http://aidsinfo.nih.gov/ContentFiles/ AdultandAdolescentGL.pdf. Accessed 15 August 2008.
2. Hammer SM, Saag M, Schechter M, et al. Treatment for adult HIV infection: 2006 recommendations of the International AIDS Society-USA Panel. JAMA 2006; 296:827-43.
3. Gazzard B, Bernard AJ, Boffito M, et al. British HIV Association (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy (2006). HIV Med 2006; 7:487-503.
4. van Leth F, Phanuphak P, Ruxrungtham K, et al; 2NN Study Team. 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; 363:1253-63.
5. US Food and Drug Administration label for Sustiva (efavirenz) capsules and tablets. Bristol-Myers Squibb Company, 2005. Available at: http://www.fda.gov/cder/foi/label/2005/020972s026,021360s013lbl.pdf. Accessed March 2007.
6. Negredo E, Ribalta J, Ferre R, et al. Efavirenz induces a striking and generalized increase of HDL-cholesterol in HIV-infected patients. AIDS 2004; 18:819-21.
7. Perez-Molina JA. Safety and tolerance of efavirenz in different antiretroviral regimens: results from a national multicenter prospective study in 1,033 HIV-infected patients. HIV Clin Trials 2002; 3:279-86.
8. Sanne I, Mommeja-Marin H, Hinkle J, et al. Severe hepatotoxicity associated with nevirapine use in HIV-infected subjects. J Infect Dis 2005; 191:825-9.
9. van LF, Andrews S, Grinsztejn B, et al. The effect of baseline CD4 cell count and HIV-1 viral load on the efficacy and safety of nevirapine or efavirenz-based first-line HAART. AIDS 2005; 19:463-71.
10. US Food and Drud Administration label for Viramune (nevirapine). Boehringer Ingelheim, 2005. Available at: http://www.fda.gov/cder/foi/ label/2005/20636s025,20933s014lbl.pdf. Accessed March 2007.
11. Grant RM, Hecht FM, Warmerdam M, et al. Time trends in primary HIV-1 drug resistance among recently infected persons. JAMA 2002; 288:181-8.
12. Richman D, Morton SC, Wrin T, et al. The prevalence of antiretroviral drug resistance in the United States. AIDS 2004; 18:1393-1401.
13. Antinori A, Zaccarelli M, Cingolani A, et al. Cross-resistance among nonnucleoside reverse transcriptase inhibitors limits recycling efavirenz after nevirapine failure. AIDS Res Hum Retroviruses 2002; 18:835-8.
14. Das K, Clark AD Jr, Lewi PJ, et al. Roles of conformational and positional adaptability in structure-based design of TMC125-R165335 (etravirine) and related non-nucleoside reverse transcriptase inhibitors that are highly potent and effective against wild-type and drug-resistant HIV-1 variants. J Med Chem 2004; 47:2550-60.
15. Gruzdev B, Rakhmanova A, Doubovskaya E, et al. A randomized, double-blind, placebo-controlled trial of TMC125 as 7-day monotherapy in antiretroviral naive, HIV-1 infected subjects. AIDS 2003; 17:2487-94.
16. Nadler JP, Berger DS, Blick G, et al. Efficacy and safety of etravirine (TMC125) in patients with highly resistant HIV-1: primary 24-week analysis. AIDS 2007; 21:F1-10.
17. 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.
18. 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.
19. Giordano M, Kelleher T, Colonno RJ, Lazzarin A, Squires K. The effects of the Roche AMPLICOR HIV-1 MONITOR UltraSensitive test ver sions 1.0 and 1.5 viral load assays and plasma collection tube type on determination of response to antiretroviral therapy and the inappropriateness of cross-study comparisons. J Clin Virol 2006; 35:420-5.
20. Johnson VA, Brun-Vezinet F, Clotet B, et al. Update of the drug resistance mutations in HIV-1: 2005. Top HIV Med 2005; 13:51-7.
21. Tambuyzer L, Vingerhoets J, Azijn H, et al. Development of a list of mutations associated with NNRTI resistance for use in clinical research [abstract 67]. In: Program and abstracts of the 5th European HIV Drug Resistance Workshop (Cascais, Portugal). 2007.
22. Squires K, Lazzarin A, Gatell JM, et al. Comparison of once-daily atazanavir with efavirenz, each in combination with fixed-dose zidovudine and lamivudine, as initial therapy for patients infected with HIV. J Acquir Immune Defic Syndr 2004; 36:1011-9.
23. Schöller M, Hoetelmans R, Beets G, et al. Substantial improvement of oral bioavailability of TMC125 using new tablet formulations in healthy volunteers [abstract 82]. In: Program and abstracts of the 6th International Workshop on Clinical Pharmacology of HIV Therapy (Quebec, Canada). 2005.