Tenofovir disoproxil fumarate, emtricitabine, and efavirenz versus fixed-dose zidovudine/lamivudine and efavirenz in antiretroviral-naive patients: Virologic, immunologic, and morphologic changes - A 96-week analysis

Journal of Acquired Immune Deficiency Syndromes

Volumn 43, Issue 5, 2006, Pages 535-540

  Pozniak, Anton L ^a,g   Gallant, Joel E ^b,g   DeJesus, Edwin ^c   Arribas, Jose R ^d,g   Gazzard, Brian ^a   Campo, Rafael E ^e,h   Chen, Shan Shan ^f,h   McColl, Damian ^f,h   Enejosa, Jeffrey ^f,h   Toole, John J ^f,h   Cheng, Andrew K ^f,h  

^a CHELSEA AND WESTMINSTER HOSPITAL   (United Kingdom)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c ORLANDO IMMUNOLOGY CENTER   (United States)

^d HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^e UNIVERSITY OF MIAMI   (United States)

^f GILEAD SCIENCES   (United States)

^g BRISTOL MYERS SQUIBB   (United States)

^h NONE   (United States)

Author keywords

Antiretroviral naive; Emtricitabine; Lamivudine; Lipoatrophy; Tenofovir; Zidovudine

Indexed keywords

ANTIRETROVIRUS AGENT; EFAVIRENZ; EMTRICITABINE; LAMIVUDINE PLUS ZIDOVUDINE; RNA DIRECTED DNA POLYMERASE INHIBITOR; TENOFOVIR DISOPROXIL; VIRUS RNA;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; AMYLASE BLOOD LEVEL; ANEMIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BODY FAT; BODY FAT DISTRIBUTION; BRONCHITIS; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; DEPRESSION; DIARRHEA; DIZZINESS; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FANCONI RENOTUBULAR SYNDROME; FATIGUE; GLOMERULUS FILTRATION RATE; GLUCOSE BLOOD LEVEL; HEADACHE; HEMATURIA; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNE RESPONSE; INSOMNIA; LABORATORY TEST; LIMB; MAJOR CLINICAL STUDY; MORPHOLOGY; NAUSEA; NEUTROPHIL COUNT; OPEN STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; RHINOPHARYNGITIS; SIDE EFFECT; SINUSITIS; TREATMENT DURATION; TREATMENT RESPONSE; TRIACYLGLYCEROL BLOOD LEVEL; VIROLOGY; VOMITING; WEIGHT GAIN;

ADENINE; ANTI-HIV AGENTS; DEOXYCYTIDINE; DRUG RESISTANCE, VIRAL; GENOTYPE; HIV INFECTIONS; HIV-1; HUMANS; LAMIVUDINE; OXAZINES; PHOSPHONIC ACIDS; RNA, VIRAL; TIME FACTORS; VIRAL LOAD; ZIDOVUDINE;

EID: 33845354174     PISSN: 15254135     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.qai.0000245886.51262.67     Document Type: Article

References (19)

1. Palella FJ Jr, Delaney KM, Moorman AC, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med. 1998;338:853-860.
2. Hammer SM, Saag MS, Schechter M, et al. Treatment for adult HIV infection: 2006 recommendations of the International AIDS Society-USA Panel. JAMA. 2006;296:827-843.
3. US Department of Health and Human Services Panel on Clinical Practices for Treatment of HIV Infection. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Available at: http:// AIDSinfo.nih.gov. Accessed October 6, 2006.
4. Gazzard B. Writing Committee British HIV Association (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy. HIV Med. 2005;(Suppl 2):1-61.
5. Carosi G, Torti C, Andreoni M, et al. Key questions in antiretroviral therapy: Italian Consensus Workshop (2005). J Antimicrob Chemother. 2006;57:1055-1064.
6. Gallant JE, DeJesus E, Arribas JR, et al. Tenofovir DF, emtricitabine and efavirenz vs. zidovudine, lamivudine and efavirenz for HIV. N Engl J Med. 2006;354:251-260.
7. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16:31-41.
8. National Institutes of Allergy and Infectious Diseases. Division of AIDS table of grading severity of adult adverse experiences. 1992. Available at: http://rcc.tech-res-intl.com/. Accessed October 6, 2006.
9. US Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for industry: antiretroviral drugs using plasma HIV RNA measurements - clinical considerations for accelerated and traditional approval. 2002. Available at: http://www.fda.gov/cder/guidance. Accessed October 6, 2006.
10. Levey AS, Bosch JP, Lewis JB, et al. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999;130:461-470.
11. Gallant JE, Staszewski S, Pozniak AL, et al. Efficacy and safety of tenofovir DF vs. stavudine in combination therapy in antiretroviral naïve patients: a 3 year randomized trial. JAMA. 2004;292:191-201.
12. Hawkins T, Veikley W, St. Claire RL, et al. Intracellular pharmacokinetics of tenofovir diphosphate, carbovir triphosphate, and lamivudine triphosphate in patients receiving triple-nucleoside regimens. J Acquir Immune Defic Syndr. 2005;39:406-411.
13. Wang LH, Begley J, St. Clair RL, et al. Pharmacokinetic and pharmacodynamic characteristics of emtricitabine support its once daily dosing for the treatment of HIV infection. AIDS Res Hum Retroviruses. 2004;20:1173-1182.
14. Johnson M, Grinsztejn B, Rodriguez C, et al. 96-Week comparison of once-daily atazanavir/ritonavir and twice-daily lopinavir/ritonavir in patients with multiple virologic failures. AIDS. 2006;20:711-718.
15. Molina JM, Wilkin A, Domingo P, et al. Once daily vs. twice daily lopinavir/ritonavir in antiretroviral naïve patients: 96 week results. Presented at: Third International AIDS Society Conference on HIV Pathogenesis and Treatment; 2005; Rio de Janeiro.
16. Dube MP, Parker RA, Tebas P, et al. Glucose metabolism, lipid, and body fat changes in antiretroviral-naive subjects randomized to nelfinavir or efavirenz plus dual nucleosides. AIDS. 2005;19:1807-1818.
17. McComsey GA, Ward DJ, Hessenthaler SM, et al. Improvement in lipoatrophy associated with highly active antiretroviral therapy in human immunodeficiency virus-infected patients switched from stavudine to abacavir or zidovudine: the results of the TARHEEL study. Clin Infect Dis. 2004;38:263-279.
18. Martin A, Smith DE, Carr A, et al. Reversibility of lipoatrophy in HIV-infected patients 2 years after switching from thymidine analogue to abacavir: the MITOX Extension Study. AIDS. 2004;18:1029-1036.
19. Moyle G, Sabin C, Cartledge J, et al. A 48 week, randomized, open-label comparative study of tenofovir DF vs. abacavir as substitutes for a thymidine analog in persons with lipoatrophy and sustained virologic suppression of HAART [abstract 44LB]. Presented at: 12th Conference on Retroviruses and Opportunistic Infections; 2005; Boston.