Efficacy and safety of etravirine (TMC125) in patients with highly resistant HIV-1: Primary 24-week analysis

AIDS

Volumn 21, Issue 6, 2007, Pages

  Nadler, Jeffrey P ^a,b   Berger, Daniel S ^b   Blick, Gary ^b   Cimoch, Paul J ^b   Cohen, Calvin J ^b   Greenberg, Richard N ^b   Hicks, Charles B ^b   Hoetelmans, Richard M W ^b   Iveson, Kathy J ^b   Jayaweera, Dushyantha S ^b   Mills, Anthony M ^b   Peeters, Monika P ^b   Ruane, Peter J ^b   Shalit, Peter ^b   Schrader, Shannon R ^b   Smith, Stephen M ^b   Steinhart, Corklin R ^b   Thompson, Melanie ^b   Vingerhoets, Johan H ^b   Voorspoels, Ellen ^b   Ward, Douglas ^b   Woodfall, Brian ^b   more..

^a UNIVERSITY OF SOUTH FLORIDA   (United States)

^b NONE

Author keywords

24 week primary analysis; Etravirine; Non nucleoside reverse transcriptase inhibitor; Randomized trial; Resistant HIV 1; TMC125

Indexed keywords

ANTIRETROVIRUS AGENT; ENFUVIRTIDE; ETRAVIRINE; LOPINAVIR PLUS RITONAVIR; RNA; RNA DIRECTED DNA POLYMERASE INHIBITOR;

ADULT; AGED; ARTHRALGIA; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEATH; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; EVALUATION; FATIGUE; FEMALE; FEVER; GENOTYPE; HEADACHE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INJECTION SITE NODULE; INJECTION SITE REACTION; INSOMNIA; LYMPHADENOPATHY; MAJOR CLINICAL STUDY; MALE; MENTAL DISEASE; NAUSEA; NEUROLOGIC DISEASE; POPULATION RESEARCH; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; RHINOPHARYNGITIS; SIDE EFFECT; SINGLE BLIND PROCEDURE; VIRUS LOAD; VOMITING;

ADULT; CD4 LYMPHOCYTE COUNT; DREAMS; DRUG ADMINISTRATION SCHEDULE; DRUG RESISTANCE, VIRAL; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; MALE; MIDDLE AGED; MOOD DISORDERS; MUTATION; PYRIDAZINES; REVERSE TRANSCRIPTASE INHIBITORS; RNA, VIRAL; TREATMENT OUTCOME; VIRAL LOAD;

EID: 34147134958     PISSN: 02699370     EISSN: None     Source Type: Journal    
DOI: 10.1097/QAD.0b013e32805e8776     Document Type: Article

References (16)

1. Rinehart AR, Lecocq P, McKenna P, Pattery T, Wasikowski B, Bacheler LT. Predicted phenotypic resistance in routine clinical samples between 1998 and 2003. Antivir Ther 2004; 9:S90.
2. Cane P, Chrystie I, Dunn D, Evans B, Geretti AM, Green H, et al. Time trends in primary resistance to HIV drugs in the United Kingdom: multicentre observational study. BMJ 2005; 331:1368.
3. Palmer S, Boltz V, Maldarelli F, Kearney M, Halvas E, Rock D, et al. Selection and persistence of non-nucleoside reverse transcriptase inhibitor-resistant HIV-1 in patients starting and stopping non-nucleoside therapy. AIDS 2006; 20:701-710.
4. Antinori A, Zaccarelli M, Cingolani A, Forbici F, Rizzo MG, Trotta MP, et al. Cross-resistance among nonnucleoside reverse transcriptase inhibitors limits recycling efavirenz after nevirapine failure. AIDS Res Hum Retroviruses 2002; 18:835-838.
5. Zhang Z, Hamatake R, Hong Z. Clinical utility of current NNRTIs and perspectives of new agents in this class under development. Antivir Chem Chemother 2004; 15:121-134.
6. Andries K, Azijn H, Thielemans T, Ludovici D, Kukla M, Heeres J, et al. TMC125, a novel next generation non-nucleoside reverse transcriptase inhibitor active against non-nucleoside reverse transcriptase inhibitor-resistant HIV-1. Antimicrob Agents Chemother 2004; 48:4680-4686.
7. Vingerhoets J, Azijn H, Fransen E, De Baere I, Smeulders L, Jochmans D, et al. TMC125 displays a high genetic barrier to the development of resistance: evidence from in-vitro selection experiments. J Virol 2005; 79:12773-12782.
8. Gruzdev B, Rakhmanova A, Doubovskaya E, Yakovlev A, Peeters M, Rinehart A, et al. A randomized, double-blind, placebo-controlled trial of TMC125 as 7-day monotherapy in antiretroviral naïve. HIV-1 infected subjects. AIDS 2003; 17:2487-2494.
9. Gazzard BG, Pozniak AL, Rosenbaum W, Yeni GP, Staszewski S, Arasteh K, et al. An open-label assessment of TMC 125, a new, next-generation NNRTI, for 7 days in HIV-1 infected individuals with NNRTI resistance. AIDS 2003; 17:F49-F54.
10. Johnson VA, Brun-Vezinet F, Clotet B, Conway B, D'Aquila RT, Demeter LM, et al. Update of the drug-resistance mutations in HIV-1: 2004. Top HIV Med 2004; 12:119-124.
11. Division of AIDS. Table for grading severity of adult adverse experiences, August 1992. Available at: http://rcc.tech-resintl.com/ DAIDS%20RCC%20Forms/TB_ToxicityTables_Adult_TRP_v01a.pdf). Accessed: 26 October 2005.
12. Scholler M, Hoetelmans R, Beets G, Vandermeulen K, Peeters M, Bastiaanse L, et al. Substantial improvement of oral bioavailability of TMC125 using new tablet formulations in healthy volunteers. In: 6th International Workshop on Clinical Pharmacology of HIV Therapy. Quebec, Canada, 28-30 April 2005. [Abstract 82].
13. Bristol-Myers Squibb Company. Food and Drug Administration label for Sustiva. Available at: http://www.fda.gov/cder/foi/label/2005/020972s026, 021360s013lbl.pdf). Accessed: 22 September 2005.
14. Van Leth F, Andrews S, Grinsztejn B, Wilkins E, Lazanas MK, Lange JM, et al. The effect of baseline CD4 cell count and HIV-1 viral load on the efficacy and safety of nevirapine or efavirenzbased first-line HAART. AIDS 2005; 19:463-471.
15. The European Agency for the Evaluation of Medicinal Products (EMEA). EMEA public statement on Viramune (nevirapine) - severe and life-threatening cutaneous and hepatic reactions. London: EMEA; 12 April 2000.
16. Boehringer Ingelheim. Food and Drug Administration label for Viramune. Available at: http://www.fda.gov/cder/foi/label/2005/20636s025, 20933s014lbl.pdf). Accessed: 5 October 2005.