Raltegravir non-inferior to nucleoside based regimens in second-line therapy with lopinavir/ritonavir over 96 weeks: A randomised open label study for the treatment of HIV-1 infection

PLoS ONE

Volumn 10, Issue 2, 2015, Pages

  Amin, Janaki ^a   Boyd, Mark A ^a   Kumarasamy, Nagalingeswaran ^b   Moore, Cecilia L ^a   Losso, Marcello H ^c   Nwizu, Chidi A ^d   Mohapi, Lerato ^e   Kerr, Stephen J ^f   Sohn, Annette H ^g   Teppler, Hedy ^h   Renjifo, Boris ⁱ   Molina, Jean Michel ^j   Emery, Sean ^a   Cooper, David A ^a  

^a UNIVERSITY OF NEW SOUTH WALES   (Australia)

^b YRG CENTRE FOR AIDS RESEARCH AND EDUCATION   (India)

^c HOSPITAL RAMOS MEJÍA   (Argentina)

^d UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^f THAI RED CROSS AIDS RESEARCH CENTRE   (Thailand)

^g Foundation for AIDS Research   (Thailand)

^h MERCK RESEARCH LABORATORIES   (United States)

ⁱ ABBVIE INC   (United States)

^j SAINT LOUIS HOSPITAL   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CHOLESTEROL; HEMOGLOBIN; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOPINAVIR PLUS RITONAVIR; LOW DENSITY LIPOPROTEIN CHOLESTEROL; NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR; RALTEGRAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; VIRUS RNA; HUMAN IMMUNODEFICIENCY VIRUS PROTEINASE INHIBITOR; INTEGRASE INHIBITOR; LOPINAVIR; RITONAVIR;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ADULT; ARTICLE; CONTROLLED STUDY; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; FEMALE; GASTROINTESTINAL DISEASE; HEMATOLOGIC DISEASE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; LUNG MYCOSIS; LYMPHATIC SYSTEM DISEASE; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; METABOLIC DISORDER; MULTICENTER STUDY; MUSCLE DISEASE; NEWBORN DISEASE; NUTRITIONAL DISORDER; PREGNANCY DISORDER; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; TREATMENT OUTCOME; TUBERCULOSIS; COMBINATION DRUG THERAPY; HIV INFECTIONS; HUMAN IMMUNODEFICIENCY VIRUS 1; SECONDARY HEALTH CARE;

HUMAN IMMUNODEFICIENCY VIRUS 1;

ADULT; DRUG THERAPY, COMBINATION; HIV INFECTIONS; HIV INTEGRASE INHIBITORS; HIV PROTEASE INHIBITORS; HIV-1; HUMANS; LOPINAVIR; MALE; RALTEGRAVIR POTASSIUM; RITONAVIR; SECONDARY CARE;

EID: 84923783265     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0118228     Document Type: Article

References (19)

1. WHO (2010) Antiretroviral Therapy for HIV Infection in Adults and Adolescents: Recommendations for a Public Health Approach: 2010 Revision. Antiretroviral Therapy for HIV Infection in Adults and Adolescents: Recommendations for a Public Health Approach: 2010 Revision. Geneva.
2. Humphreys EH, Chang LW, Harris J (2010) Antiretroviral regimens for patients with HIV who fail firstline antiretroviral therapy. Cochrane Database Syst Rev: CD006517.
3. Boyd MA, Kumarasamy N, Moore CL, Nwizu C, Losso MH, et al. (2013) Ritonavir-boosted lopinavir plus nucleoside or nucleotide reverse transcriptase inhibitors versus ritonavir-boosted lopinavir plus raltegravir for treatment of HIV-1 infection in adults with virological failure of a standard first-line ART regimen (SECOND-LINE): a randomised, open-label, non-inferiority study. Lancet 381: 2091-2099. doi: 10.1016/S0140-6736(13)61164-2 PMID: 23769235
4. Paton NI, Kityo C, Hoppe A, Reid A, Kambugu A, et al. (2014) Assessment of second-line antiretroviral regimens for HIV therapy in Africa. N Engl J Med 371: 234-247. doi: 10.1056/NEJMoa1311274 PMID: 25014688
5. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, et al. (1999) 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 130: 461-470. PMID: 10075613
6. Chesney MA, Ickovics JR, Chambers DB, Gifford AL, Neidig J, et al. (2000) Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient Care Committee & Adherence Working Group of the Outcomes Committee of the Adult AIDS Clinical Trials Group (AACTG). AIDS Care 12: 255-266. PMID: 10928201
7. Lifson AR, Group IERCW, Belloso WH, Davey RT, Duprez D, et al. (2010) Development of diagnostic criteria for serious non-AIDS events in HIV clinical trials. HIV Clin Trials 11: 205-219. doi: 10.1310/hct1104-205 PMID: 20974576
8. D'Agostino RB Sr, Grundy S, Sullivan LM, Wilson P, Group CHDRP (2001) Validation of the Framingham coronary heart disease prediction scores: results of a multiple ethnic groups investigation. JAMA 286: 180-187. PMID: 11448281
9. Wilson PW, D'Agostino RB, Parise H, Sullivan L, Meigs JB (2005) Metabolic syndrome as a precursor of cardiovascular disease and type 2 diabetes mellitus. Circulation 112: 3066-3072. PMID: 16275870
10. Smith F, Hammerstrom T, Soon G, Zhou S, Chen BB, et al. (2011) A Meta-analysis to Assess the FDA DAVP's TLOVR Algorithm in HIV Submissions. Drug Information Journal 45: 291-300.
11. Moyle G, Sawyer W, Law M, Amin J, Hill A (2004) Changes in hematologic parameters and efficacy of thymidine analogue-based, highly active antiretroviral therapy: a meta-analysis of six prospective, randomized, comparative studies. Clin Ther 26: 92-97. PMID: 14996521
12. Goicoechea M, Liu S, Best B, Sun S, Jain S, et al. (2008) Greater tenofovir-associated renal function decline with protease inhibitor-based versus nonnucleoside reverse-transcriptase inhibitor-based therapy. J Infect Dis 197: 102-108. doi: 10.1086/524061 PMID: 18171292
13. Morlat P, Vivot A, Vandenhende MA, Dauchy FA, Asselineau J, et al. (2013) Role of traditional risk factors and antiretroviral drugs in the incidence of chronic kidney disease, ANRS CO3 Aquitaine cohort, France, 2004-2012. PLoS One 8: e66223. doi: 10.1371/journal.pone.0066223 PMID: 23776637
14. Nishijima T, Gatanaga H, Shimbo T, Komatsu H, Endo T, et al. (2013) Switching tenofovir/emtricitabine plus lopinavir/r to raltegravir plus Darunavir/r in patients with suppressed viral load did not result in improvement of renal function but could sustain viral suppression: a randomized multicenter trial. PLoS One 8: e73639. doi: 10.1371/journal.pone.0073639 PMID: 23951362
15. Campo R, DeJesus E, Bredeek UF, Henry K, Khanlou H, et al. (2013) SWIFT: prospective 48-week study to evaluate efficacy and safety of switching to emtricitabine/tenofovir from lamivudine/abacavir in virologically suppressed HIV-1 infected patients on a boosted protease inhibitor containing antiretroviral regimen. Clin Infect Dis 56: 1637-1645. doi: 10.1093/cid/cis1203 PMID: 23362296
16. Behrens G, Maserati R, Rieger A, Domingo P, Abel F, et al. (2012) Switching to tenofovir/emtricitabine from abacavir/lamivudine in HIV-infected adults with raised cholesterol: effect on lipid profiles. Antivir Ther 17: 1011-1020. doi: 10.3851/IMP2305 PMID: 22910324
17. Stone NJ, Robinson J, Lichtenstein AH, Bairey Merz CN, Lloyd-Jones DM, et al. (2013) 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol.
18. Gotuzzo E, Markowitz M, Ratanasuwan W, Smith G, Prada G, et al. (2012) Sustained efficacy and safety of raltegravir after 5 years of combination antiretroviral therapy as initial treatment of HIV-1 infection: final results of a randomized, controlled, phase II study (Protocol 004). J Acquir Immune Defic Syndr 61: 73-77. PMID: 22743596
19. Reynes J, Trinh R, Pulido F, Soto-Malave R, Gathe J, et al. (2013) Lopinavir/ritonavir combined with raltegravir or tenofovir/emtricitabine in antiretroviral-naive subjects: 96-week results of the PROGRESS study. AIDS Res Hum Retroviruses 29: 256-265. doi: 10.1089/AID.2011.0275 PMID: 22730929