Efficacy and safety of TMC278 in antiretroviral-naive HIV-1 patients: Week 96 results of a phase IIb randomized trial

AIDS

Volumn 24, Issue 1, 2010, Pages 55-65

  Pozniak, Anton L ^a   Morales Ramirez, Javier ^b   Katabira, Elly ^c   Steyn, Dewald ^d   Lupo, Sergio H ^e   Santoscoy, Mario ^f   Grinsztejn, Beatriz ^g   Ruxrungtham, Kiat ^h   Rimsky, Laurence T ⁱ   Vanveggel, Simon ⁱ   Boven, Katia ^j  

^a CHELSEA AND WESTMINSTER HOSPITAL NHS FOUNDATION TRUST   (United Kingdom)

^b Clinical Research Puerto Rico Inc   (Puerto Rico)

^c MAKERERE UNIVERSITY   (Uganda)

^d UNIVERSITY OF THE FREE STATE   (South Africa)

^e UNIVERSIDAD NACIONAL DE ROSARIO   (Argentina)

^f INSTITUTO MEXICANO DEL SEGURO SOCIAL   (Mexico)

^g Funda??o Oswaldo Cruz   (Brazil)

^h CHULALONGKORN UNIVERSITY   (Thailand)

ⁱ TIBOTEC BVBA   (Belgium)

^j Tibotec Inc   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

EFAVIRENZ; RILPIVIRINE; RNA DIRECTED DNA POLYMERASE INHIBITOR;

ADULT; AGED; ANTIVIRAL ACTIVITY; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; CD4 LYMPHOCYTE COUNT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; IMMUNE RESPONSE; INCIDENCE; MAJOR CLINICAL STUDY; MALE; NAUSEA; NONHUMAN; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SOMNOLENCE; UNPLEASANT DREAM; VERTIGO; VIRUS LOAD;

ADULT; AGED; ANTI-HIV AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG RESISTANCE, VIRAL; FEMALE; HIV INFECTIONS; HIV REVERSE TRANSCRIPTASE; HIV-1; HUMANS; MALE; MIDDLE AGED; NITRILES; PYRIMIDINES; REVERSE TRANSCRIPTASE INHIBITORS; TREATMENT OUTCOME; VIRAL LOAD;

EID: 73649148381     PISSN: 02699370     EISSN: 14735571     Source Type: Journal    
DOI: 10.1097/QAD.0b013e32833032ed     Document Type: Article

References (28)

1. Basavapathruni A, Bailey CM, Anderson KS. Defining a molecular mechanism of synergy between nucleoside and nonnu-cleoside AIDS drugs. J Biol Chem 2004; 279:6221-6224.
2. Weiser SD, Guzman D, Riley ED, Clark R, Bangsberg DR. Higher rates of viral suppression with nonnucleoside reverse transcriptase inhibitors compared to single protease inhibitors are not explained by better adherence. HIV Clin Trials 2004; 5:278-287.
3. van der Valk M, Kastelein JJ, Murphy RL, van Leth F, Katlama C, Horban A, et al. Nevirapine-containing antiretroviral therapy in HIV-1 infected patients results in an antiatherogenic lipid profile. AIDS 2001; 15:2407-2414.
4. Moyle G. The emerging roles of nonnucleoside reverse tran-scriptase inhibitors in antiretroviral therapy. Drugs 2001; 61:19-26.
5. Riddler SA, Haubrich R, DiRienzo AG, Peeples L, Powderly WG, Klingman KL, et al. Class-sparing regimens for initial treatment of HIV-1 infection. N Engl J Med 2008; 358:2095-2106.
6. Richman DD, Morton SC, Wrin T, Hellmann N, Berry S, Shapiro MF, et al. The prevalence of antiretroviral drug resistance in the United States. AIDS 2004; 18:1393-1401.
7. Mellors JW, Dutschman GE, Im GJ, Tramontano E, Winkler SR, Cheng YC. In vitro selection and molecular characterization of human immunodeficiency virus-1 resistant to nonnucleoside inhibitors of reverse transcriptase. Mol Pharmacol 1992; 41:446-451.
8. Richman DD, Havlir D, Corbeil J, Looney D, Ignacio C, Spector SA, et al. Nevirapine resistance mutations of human immunodeficiency virus type 1 selected during therapy. J Virol 1994; 68:1660-1666.
9. Vandamme AM, Debyser Z, Pauwels R, DeVreeseK, Goubau P, Youle M, et al. Characterization of HIV-1 strains isolated from patients treated with TIBO R82913. AIDS Res Hum Retro-viruses 1994; 10:39-46.
10. Delaugerre C, Rohban R, Simon A, Mouroux M, Tricot C, Agher R, et al. Resistance profile and cross-resistance of HIV-1 among patients failing a nonnucleoside reverse tran-scriptase inhibitor-containing regimen. J Med Virol 2001; 65:445-448.
11. 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.
12. 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; 3:279-286.
13. van Leth F, Phanuphak P, Ruxrungtham K, Baraldi E, Miller S, Gazzard B, et al. 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.
14. DHHS Guidelines. http://AIDSinfo.nih.gov [Accessed 18 June 2009].
15. FDA label for Viramune (nevaripine) tablets and oral suspension. Boehringer Ingelheim, 2008. http://bidocs.boehringer-in-gelheim.com/BIWebAccess/ ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/ Viramune/Viramune. pdf [Accessed 18 June 2009].
16. FDA label for Sustiva (efavirenz) capsules and tablets. Bristol-Myers Squibb Company, 2009. http://packageinserts.bms.com/ pi/pi-sustiva.pdf [Accessed 18 June 2009].
17. FDA label for Intelence (etravirine) tablets. Tibotec Therapeutics, 2008. http://www.intelence-info.com/intelence/assets/pdf/ INTELENCE-PI.pdf [Accessed 18 June 2009].
18. Intelence (etravirine). Canadian prescribing information. Tibotec, Inc. April 2008.
19. de Béthune M-P, Andries K, Azijn H, Guillemont J, Heeres J, Vingerhoets J, et al. TMC278, a new potent NNRTI, with an increased barrier to resistance and good pharmaco kinetic profile. 12th Conference on Retroviruses and Opportunistic Infections; 22-25 February 2005; Boston, MA, USA. Abstract and Poster 556.
20. Janssen PA, Lewi PJ, Arnold E, Daeyaert F, de Jonge M, Heeres J, et al. In search of a novel anti-HIV drug: multidisciplinary coordination in the discovery of 4-[[4-[[4-[(1E)-2-cyanoethe nyl]-2, 6-dimethylphenyl]amino]-2- pyrimidinyl]amino]benzo nitrile (R278474, rilpivirine). J Med Chem 2005; 48:1901-1909.
21. Das K, Bauman JD, Clark AD Jr, Frenkel YV, Lewi PJ, Shatkin AJ, et al. High-resolution structures of HIV-1 reverse transcriptase/ TMC278 complexes: strategic flexibility explains potency against resistance mutations. Proc Natl Acad Sci U S A 2008; 105:1466-1471.
22. Goebel F, Yakovlev A, Pozniak AL, Vinogradova E, Boogaerts G, Hoetelmans R, et al. Short-term antiviral activity of TMC278-a novel NNRTI-in treatment-näive HIV-1-infected subjects. AIDS 2006; 20:1721-1726.
23. Tambuyzer L, Vingerhoets J, Azijn H, Staes M, Kraus G, Rimsky LT, et al. Deployment of a list of mutations associated with NNRTI resistance for use in clinical research. 5th European HIV Drug Resistance Workshop; 28-30 March 2007; Cascais, Portugal. Poster 67.
24. Pocock S, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975; 31:103-115.
25. FDA Guidance for Industry. Antiretroviral drugs using plasma HIV RNA measurements-clinical considerations for accelerated and traditional approval, prepared by the Division of Antiviral Drug Products: Office of Drug Evaluation IV in the Centre for Drug Evaluation and Research (CDER), Appendix B; October2002. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM070968.pdf [Accessed 18 June 2009].
26. Division of Acquired Immune Deficiency Syndrome (DAIDS) table for grading the severity of adult and pediatric adverse events. Version 1. 28 December 2004.
27. Gallant JE, Staszewski S, Pozniak AL, DeJesus E, Suleiman JM, Miller MD, et al. Efficacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients: a 3-year randomized trial. JAMA 2004; 292:191-201.
28. Pozniak AL, Gallant JE, DeJesus E, Arribas JR, Gazzard B, Campo RE, et al. Tenofovir disoproxil fumarate, emtricitabine, and efavirenz versus fixed-dose zidovudine/lamivudine and efavirenz in antiretroviral-naive patients: virologic, immuno-logic, and morphologic changes-a 96-week analysis. J Acquir Immune Defic Syndr 2006; 43:535-540.