Erratum: Department of Error (Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study (2013) 382(9893) (700–708), (S0140673613612210), (10.1016/S0140-6736(13)61221-0));Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: Week 48 results from the randomised, double-blind, non-inferiority SAILING study

The Lancet

Volumn 382, Issue 9893, 2013, Pages 700-708

  Cahn, Pedro ^a   Pozniak, Anton L ^b   Mingrone, Horacio ^c   Shuldyakov, Andrey ^d   Brites, Carlos ^e   Andrade Villanueva, Jaime F ^f   Richmond, Gary ^g   Buendia, Carlos Beltran ^h   Fourie, Jan ⁱ   Ramgopal, Moti ^j   Hagins, Debbie ^k   Felizarta, Franco ^l   Madruga, Jose ^m   Reuter, Tania ⁿ   Newman, Tamara ^o   Small, Catherine B ^p   Lombaard, John ^q   Grinsztejn, Beatriz ^r   Dorey, David ^s   Underwood, Mark ^t   Griffith, Sandy ^t   Min, Sherene ^t   more..

^a FUNDACIÓN HUÉSPED   (Argentina)

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

^c Fundacion IDEAA   (Argentina)

^d Saratov Regional Centre of Prophylactic AIDS   (Russian Federation)

^e FEDERAL UNIVERSITY OF BAHIA   (Brazil)

^f UNIVERSITY OF GUADALAJARA   (Mexico)

^g BROWARD HEALTH MEDICAL CENTER   (United States)

^h HOSPITAL BARROS LUCO TRUDEAU   (Chile)

ⁱ Fourie Medical Centre   (United Kingdom)

^j Midway Immunology and Research Center   (United States)

^k Chatham CARE Center   (United States)

^l Private Practice   (United States)

^m Centro de Referencia e Treinamento DST/AIDS   (Brazil)

ⁿ FEDERAL UNIVERSITY OF ESPÍRITO SANTO   (Brazil)

^o INSTITUTO DE INFECTOLOGIA EMÍLIO RIBAS   (Brazil)

^p NEW YORK MEDICAL COLLEGE   (United States)

^q JOSHA Research   (South Africa)

^r Funda??o Oswaldo Cruz   (Brazil)

^s GLAXOSMITHKLINE   (Canada)

^t GLAXOSMITHKLINE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DOLUTEGRAVIR; PLACEBO; RALTEGRAVIR; VIRUS RNA;

ADULT; ARTHRALGIA; ARTICLE; CONTROLLED STUDY; COUGHING; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HEADACHE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; INFLUENZA; MAJOR CLINICAL STUDY; MALE; NAUSEA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; RHINOPHARYNGITIS; TREATMENT DURATION; TREATMENT OUTCOME; UPPER ABDOMINAL PAIN; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VOMITING;

EID: 84882912698     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(13)62736-1     Document Type: Erratum

References (29)

1. JL Lennox, E Dejesus, DS Berger et al. Raltegravir versus efavirenz regimens in treatment-naive HIV-1-infected patients: 96-week efficacy, durability, subgroup, safety, and metabolic analyses J Acquir Immune Defic Syndr 55 2010 39 48
2. PE Sax, E DeJesus, A Mills et al. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus co-formulated efavirenz, emtricitabine, and tenofovir for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3 trial, analysis of results after 48 weeks Lancet 379 2012 2439 2448
3. RT Steigbigel, DA Cooper, PN Kumar et al. Raltegravir with optimized background therapy for resistant HIV-1 infection N Engl J Med 359 2008 339 354
4. JM Molina, A Lamarca, J Andrade-Villanueva et al. Efficacy and safety of once daily elvitegravir versus twice daily raltegravir in treatment-experienced patients with HIV-1 receiving a ritonavir-boosted protease inhibitor: randomised, double-blind, phase 3, non-inferiority study Lancet Infect Dis 12 2012 27 35
5. JJ Eron Jr, JK Rockstroh, J Reynes et al. Raltegravir once daily or twice daily in previously untreated patients with HIV-1: a randomised, active-controlled, phase 3 non-inferiority trial Lancet Infect Dis 11 2011 907 915
6. P German, D Warren, S West, J Hui, BP Kearney Pharmacokinetics and bioavailability of an integrase and novel pharmacoenhancer-containing single-tablet fixed-dose combination regimen for the treatment of HIV J Acquir Immune Defic Syndr 55 2010 323 329
7. DJ Hazuda, MD Miller, BY Nguyen, J Zhao for the P005 Study Team Resistance to the HIV-integrase inhibitor raltegravir: analysis of protocol 005, a phase II study in patients with triple-class resistant HIV-1 infection Antivir Ther 12 2007 S10
8. DJ McColl, S Fransen, S Gupta et al. Resistance and cross-resistance to first generation integrase inhibitors: insights from a phase II study of elvitegravir (GS-9137) Antivir Ther 12 2007 S11
9. DA Cooper, RT Steigbigel, JM Gatell et al. Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection N Engl J Med 359 2008 355 365
10. E DeJesus, JK Rockstroh, K Henry et al. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial Lancet 379 2012 2429 2438
11. C Garrido, J Villacian, N Zahonero et al. Broad phenotypic cross-resistance to elvitegravir in HIV-infected patients failing on raltegravir-containing regimens Antimicrob Agents Chemother 56 2012 2873 2878
12. KE Hightower, R Wang, F Deanda et al. Dolutegravir (S/GSK1349572) exhibits significantly slower dissociation than raltegravir and elvitegravir from wild-type and integrase inhibitor-resistant HIV-1 integrase-DNA complexes Antimicrob Agents Chemother 55 2011 4552 4559
13. S Min, I Song, J Borland et al. Pharmacokinetics and safety of S/GSK1349572, a next-generation HIV integrase inhibitor, in healthy volunteers Antimicrob Agents Chemother 54 2010 254 258
14. F Raffi, A Rachlis, HJ Stellbrink et al. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study Lancet 381 2013 735 743
15. Walmsley S, Antela A, Clumeck N, et al. Dolutegravir (DTG; S/GSK1349572) + abacavir/lamivudine once daily statistically superior to tenofovir/ emtricitabine/efavirenz: 48-week results - SINGLE (ING114467). 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy; San Francisco, CA, USA; Sept 9-12, 2012; abstr H-556b.
16. Nichols G, Mills A, Grossberg R, et al. Antiviral activity of dolutegravir in subjects with failure on an integrase inhibitor-based regimen: week 24 phase 3 results from VIKING-3. 11th International Congress on Drug Therapy in HIV Infection. Glasgow, UK; Nov 11-15, 2012; abstr O232.
17. I Song, J Borland, S Min et al. Effects of etravirine alone and with ritonavir-boosted protease inhibitors on the pharmacokinetics of dolutegravir Antimicrob Agents Chemother 55 2011 3517 3521
18. Centers for Disease Control and Prevention 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871. htm (accessed Sept 20, 2012).
19. Division of AIDS table for grading the severity of adult and pediatric adverse events National Institutes of Allergy and Infectious Diseases, Division of Acquired Immunodeficiency Syndrome http://rsc.tech-res.com/Document/ safetyandpharmacovigilance/Table-for-Grading-Severity-of-Adult-Pediatric- Adverse-Events.pdf (accessed Jan 9, 2012).
20. TF Liu, RW Shafer Web resources for HIV type 1 genotypic-resistance test interpretation Clin Infect Dis 42 2006 1608 1618
21. Committee for Medicinal Products for Human Use (CHMP) Guideline on the clinical development of medicinal products for the treatment of HIV infection (draft) http://www.emea.europa.eu/pdfs/human/ewp/063302enrev2.pdf Oct 18, 2007 (accessed May 15, 2013).
22. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) International Conference on Harmonisation (ICH). ICH Guidance for Industry: E 10 Choice of Control Group and Related Issues in Clinical Trials hppt://www.fda.gov/CBER/gdlns/clincontr0501.htm May, 2001 (accessed May 15, 2013).
23. F Smith, T Hammerstrom, G Soon et al. A meta-analysis to assess the FDA DAVP's TLOVR algorithm in HIV submissions Drug Inf J 45 2011 291 300
24. NA Margot, RM Hluhanich, GS Jones et al. In vitro resistance selections using elvitegravir, raltegravir, and two metabolites of elvitegravir M1 and M4 Antiviral Res 93 2012 288 296
25. T Mesplède, PK Quashie, N Osman et al. Viral fitness cost prevents HIV-1 from evading dolutegravir drug pressure Retrovirology 10 2013 22
26. J Kastrup, P Petersen, R Bartram, JM Hansen The effect of trimethoprim on serum creatinine Br J Urol 57 1985 265 268
27. J Koteff, J Borland, S Chen et al. A phase 1 study to evaluate the effect of dolutegravir on renal function via measurement of iohexol and para-aminohippurate clearance in healthy subjects Br J Clin Pharmacol 75 2013 990 996
28. Lepist EI, Murray BP, Tong L, Roy A, Bannister R, Ray A. Effect of cobicistat and ritonavir on proximal renal tubular cell uptake and efflux transporters. 51st Interscience Conference on Antimicrobial Agents and Chemotherapy; Chicago, IL, USA; Sept 17-20, 2011; abstr A1-1724.
29. I Song, J Borland, S Chen et al. Metabolism and drug-drug interaction profile of dolutegravir (DTG, S/GSK1349572) [abstract O-07] Rev Antivir Ther Infect Dis 3 2012 9