Once-daily versus twice-daily lamivudine, in combination with zidovudine and efavirenz, for the treatment of antiretroviral-naive adults with HIV infection: A randomized equivalence trial

Clinical Infectious Diseases

Volumn 39, Issue 3, 2004, Pages 411-418

  DeJesus, Edwin ^a   McCarty, Debra ^c   Farthing, Charles F ^d   Shortino, Denise D ^c   Grinsztejn, Beatriz ^f   Thomas, Deborah A ^c   Schrader, Shannon R ^e   Castillo, Steve A ^c   Sension, Michael G ^b   Gough, Kevin ^g   Madison, Sam J ^c  

^a IDC Research Initiative   (United States)

^b North Broward Hospital District   (United States)

^c GLAXOSMITHKLINE   (United States)

^d AHF Research Center   (United States)

^e Montrose Clinic   (United States)

^f Funda??o Oswaldo Cruz   (Brazil)

^g ST MICHAEL'S HOSPITAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRETROVIRUS AGENT; CD4 ANTIGEN; EFAVIRENZ; LAMIVUDINE; VIRUS RNA; ZIDOVUDINE;

ADULT; AGED; ANTIBIOTIC THERAPY; ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE COURSE; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE REGIMEN; FEMALE; HUMAN; HUMAN CELL; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NONHUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TREATMENT FAILURE; VIRUS LOAD;

ADOLESCENT; ADULT; AGED; ANTI-HIV AGENTS; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; CD4 LYMPHOCYTE COUNT; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG RESISTANCE, VIRAL; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; LAMIVUDINE; MALE; MIDDLE AGED; OXAZINES; REVERSE TRANSCRIPTASE INHIBITORS; RNA, VIRAL; VIRAL LOAD; ZIDOVUDINE;

EID: 3943101413     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/422143     Document Type: Article

References (29)

1. Palella FJ Jr, Delaney KM, Moorman AC, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. N Engl J Med 1998; 338:853-60.
2. Hogg RS, Yip B, Kully C, et al. Improved survival among HIV-infected patients after initiation of triple-drug antiretroviral regimens. CMAJ 1999; 160:659-65.
3. Raboud JM, Harris M, Rae S, Montaner JSG. Impact of adherence on duration of virological suppression among patients receiving combination antiretroviral therapy. HIV Medicine 2002; 3:118-24.
4. Paterson DL, Swindells S, Mohr J, et al. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med 2000; 133:21-30.
5. Bangsberg DR, Hecht FM, Charlebois ED, et al. Adherence to protease inhibitors, HIV-1 viral load, and development of drug resistance in an indigent population. AIDS 2000; 14:357-66.
6. Cahn P. Potential advantages of a compact triple nucleoside regimen: efficacy and adherence with Combivir/abacavir versus Combivir/indinavir in an open-label randomised comparative study (CNAB3014) [abstract 695]. The CNAB3014 Team. In: Program and abstracts of the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy (Toronto, Canada). Washington DC: American Society for Microbiology, 2000:293.
7. Bartlett JA, DeMasi R, Quinn J, Moxham C, Rousseau F. Overview of the effectiveness of triple combination therapy in antiretroviral-naïve HIV-1 infected adults. AIDS 2001; 15:1369-77.
8. Boyle B. Efficacy and safety of once-daily antiretroviral therapy. AIDS Reader 2002; 12:90-96, 109.
9. Rosenbach KA, Allison R, Nadler JP. Daily dosing of highly active antiretroviral therapy. Clin Infect Dis 2002; 34:686-92.
10. Perry CM, Faulds D. Lamivudine, a review of its antiviral activity, pharmacokinetic properties and therapeutic efficacy in the management of HIV infection. Drugs 1997; 53:657-80.
11. Moore KHP, Barrett JE, Shaw S, et al. The pharmacokinetics of lamivudine phosphorylation in peripheral blood mononuclear cells from patients infected with HIV-1. AIDS 1999; 13:2239-50.
12. Yuen GJ, Lou Y, Bumgarner NT, et al. Equivalent steady-state pharmacokinetics of lamivudine in plasma and of lamivudine triphosphate within cells following administration of lamivudine at 300 mg once daily versus 150 mg twice daily. Antimicrob Agents Chemother 2004; 48:176-82.
13. Bruno R, Regazzi MB, Ciappina V, et al. Comparison of the plasma pharmacokinetics of lamivudine drug twice and once daily administration in patients with HIV. Clin Pharmacokinet 2001; 40: 695-700.
14. Landman R, Schiemann R, Thiam S, et al. Once-a-day highly active antiretroviral therapy in treatment-naïve HIV-1-infected adults in Senegal. AIDS 2003; 17:1017-22.
15. Staszewski S, Harbel A, Carlebach A, et al. A simple, once-daily dosing regimen for treating HIV-1 infection in intravenous drug users. HIV Medicine 2000; 1:162-3.
16. Division of AIDS. Division of AIDS table for grading the severity of adult adverse experiences. Rockville, MD: National Institute of Allergy and Infectious Diseases, 1996.
17. Committee fur Proprietary Medicinal Products. Points to consider on switching between superiority and noninferiority. Available at: http:// www.emea.ea.int/pdfs/human/ewp/048299en.pdf. Accessed 6 July 2004.
18. De Mendoza C, Soriano V, Perez-Olmeda M, Rodriguez-Rosado R, Gonzalez-Lahoz J. Efficacy and safety of didanosine and lamivudine both once daily plus indinavir in human immunodeficiency virus-infected patients. J Hum Virol 2000; 3:335-40.
19. Mole L, Schmidgall D, Holodniy M. A pilot trial of indinavir, ritonavir, didanosine, and lamivudine in a once-daily four-drug regimen for HIV infection. JAIDS 2001; 27:260-5.
20. Staszewski S, Haberl A, Gute P, Nisius G, Miller V, Carlebach A. Nevirapine/didanosine/lamivudine once-daily in HIV-1-infected intravenous drug users. Antivir Ther 1998; 3(Suppl 4):55-6.
21. Reiger A, Hein U, Schon H, et al. Nevirapine + ddl + 3TC - first experience with a once-daily dosing combination [abstract 697]. In: Program and abstracts of the 5th Conference on Retroviruses and Opportunistic Infections (Chicago). Alexandria, VA: Foundation for Retrovirology and Human Health, 1998:209.
22. Woodward WC, Lash J, Doerfler RE. Long-term efficacy of protease inhibitor (PI) induced HIV-1 suppression followed by switch to non-PI maintenance antiretroviral therapy (ART) [abstract 372]. In: Program and abstracts of the 37th Annual Meeting of the Infectious Diseases Society of America (IDSA) (Philadelphia). Alexandria, VA: Infectious Diseases Society of America, 1999:104.
23. Pernestorfer-Schoen H, Hein U, Thoeny S, et al. Nevirapine (NVP) + didanosine (DDI) + lamivudine (3TC): first experience with a once-daily dosing antiretroviral combination therapy [abstract 32393]. In: Program and abstracts of the 12th World AIDS Conference (Geneva). Geneva: World Health Organization, 1998:600.
24. Proencal J, Xavier A, Britto P, Soares S, Pocas J. Once daily therapy with nevirapine, didanosine, lamivudine in a non-adherent population [abstract TuPeB3231; CD-ROM only]. In: Program and abstracts of the 13th International AIDS Conference (Durban). 2000.
25. Maggiolo F, Migliorino M, Maserati R, et al. Virological and immunological responses to a once-a-day antiretroviral regimen with didanosine, lamivudine and efavirenz. Antivir Ther 2001; 6:249-53.
26. DeJesus E, Herrera G, Teolfilo E, et al. Abacavir BID vs. zidovudine BID in combination with 3TC and efavirenz in ART naïve subjects: CNA30024 48-week final results [abstract H-446]. In: Program and abstracts of the 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy (Chicago). Washington DC: American Society for Microbiology, 2003:305.
27. Vavro C, McCarty D, Shortino D, Hetherington S. Genotypic analysis of HIV-1 from subjects with virologic breakthrough while taking 3TC once daily vs 3TC BID with EFV and ZDV [abstract/poster H-2052]. In: Program and abstracts of the 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy (San Diego). Washington DC: American Society for Microbiology, 2002:292.
28. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther 2001; 23:1296-310.
29. Ruane P, Richman GJ, DeJesus E, et al. Pharmacodynamic effects of zidovudine 600 mg once daily versus zidovudine 300 mg twice daily in therapy-naïve patients infected with human immunodeficiency virus. Pharmacotherapy 2004; 24:307-12.