SOLO: 48-week efficacy and safety comparison of once-daily fosamprenavir /ritonavir versus twice-daily nelfinavir in naive HIV-1-infected patients

AIDS
Joseph C GatheJane Yeo

Abstract

To compare the magnitude and durability of the antiviral response to fosamprenavir (FPV) plus ritonavir (RTV) once-daily (FPV/r QD) with nelfinavir twice-daily (NFV BID), each administered with abacavir and lamivudine twice-daily. An international, phase III, randomized, open-label study in antiretroviral therapy-naive, HIV-infected adults. Patients with advanced HIV disease received FPV/r QD (n = 322) or NFV BID (n = 327). At week 48, 69% of patients in the FPV/r QD group and 68% in the NFV BID group had plasma HIV-1 RNA (vRNA) < 400 copies/ml, whereas 55% of patients in the FPV/r QD group and 53% in the NFV BID group had vRNA < 50 copies/ml (intent to treat, rebound/discontinuation = failure). More patients in the NFV BID group (17%) experienced virological failure than in the FPV/r QD group (7%). Efficacy of FPV/r QD was maintained in patients with CD4+ cell counts < 50 x 10 cells/l or vRNA >/= 100 000 copies/ml at entry. At week 48, median CD4+ cell counts were increased to 203 x 10 cells/l (FPV/r QD group) and 207 x 10 cells/l (NFV BID group). Both regimens were generally well tolerated. Diarrhea was more common on NFV BID than on FPV/r QD (16 versus 9%; P = 0.008). Fasting lipid profile results were generally favorable in...Continue Reading

References

Mar 18, 2000·Antimicrobial Agents and Chemotherapy·C J PetropoulosJ M Whitcomb
May 23, 2001·JAMA : the Journal of the American Medical Association·UNKNOWN Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults
Nov 28, 2001·JAMA : the Journal of the American Medical Association·A N PhillipsUNKNOWN EuroSIDA Study Group
Feb 28, 2002·Patient Education and Counseling·Linda FogartyRichard Levy
Jun 28, 2002·The New England Journal of Medicine·Sharon WalmsleyUNKNOWN M98-863 Study Team
Jul 4, 2002·JAMA : the Journal of the American Medical Association·Patrick G YeniPaul A Volberding
Dec 12, 2003·The New England Journal of Medicine·Gregory K RobbinsUNKNOWN AIDS Clinical Trials Group 384 Team

❮ Previous
Next ❯

Citations

Nov 26, 2005·Expert Review of Anti-infective Therapy·Albert M L Anderson, John A Bartlett
Sep 17, 2005·AIDS Patient Care and STDs·Paul E Sax, Joseph C Gathe
Jan 26, 2006·The Journal of the Association of Nurses in AIDS Care : JANAC·Charles RainesGlenn J Treisman
Oct 18, 2005·Drugs·Caroline M PerryRisto S Cvetković
Sep 22, 2006·BMC Medical Research Methodology·Jean-Jacques ParientiVéronique Massari
Dec 13, 2006·HIV Clinical Trials·Giuliano RizzardiniMario Clerici
Nov 16, 2006·HIV Medicine·B GazzardUNKNOWN Writing Committee, British HIV Association
Jul 27, 2006·Expert Opinion on Drug Metabolism & Toxicology·Montserrat Olmo, Daniel Podzamczer
May 17, 2007·International Journal of Clinical Practice·L Waters, M Nelson
Jun 6, 2007·Expert Review of Anti-infective Therapy·Harrys A Torres, Roberto C Arduino
May 16, 2008·Clinical Drug Investigation·Carlo GiaquintoRuggero D'Elia
Sep 1, 2006·Current Opinion in HIV and AIDS·Paul E Sax
Nov 1, 2007·Current Opinion in HIV and AIDS·Curtis L Cooper
Nov 26, 2009·Expert Opinion on Drug Metabolism & Toxicology·Charurut SomboonwitAna Paula Velez
Sep 1, 2006·Current Opinion in HIV and AIDS·Rebeca M Plank, Daniel R Kuritzkes
Jun 17, 2009·Expert Opinion on Pharmacotherapy·José Vicente Fernández-MonteroVicente Soriano
Feb 17, 2010·Clinical Trials : Journal of the Society for Clinical Trials·Linda WittkopRodolphe Thiébaut
Dec 1, 2011·The Journal of Antimicrobial Chemotherapy·José A Pérez-MolinaSantiago Moreno
May 15, 2012·International Journal of STD & AIDS·G BlickUNKNOWN Boosting Once-daily Lexiva Delivery with ritonavir 100 mg QD [BOLD100] Study Team
Jun 19, 2013·BMC Medicine·Ricardo A Franco, Michael S Saag
Feb 24, 2018·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Romina QuerciaDaniel Kuritzkes
May 11, 2005·Journal of the International Association of Physicians in AIDS Care : JIAPAC·Frank A Post, Philippa J Easterbrook
Jul 4, 2006·Indian Journal of Pediatrics·Pimpanada ChearskulBasim Asmar
Dec 8, 2006·Expert Opinion on Pharmacotherapy·Laura Waters, Graeme Moyle
Dec 4, 2004·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Calvin J Cohen, Brian A Boyle
May 16, 2008·Clinical Pharmacokinetics·Geoffrey J YuenGary E Pakes
Jul 30, 2008·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Ravindra GuptaDeenan Pillay
Sep 13, 2006·Journal of Acquired Immune Deficiency Syndromes : JAIDS·John A BartlettUNKNOWN Clinically Significant Long-Term Antiretroviral Sequential Sequencing Study (CLASS) Team
Sep 28, 2007·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Alessandro Soria, Adriano Lazzarin
Jun 6, 2007·Current HIV/AIDS Reports·Joel E Gallant
Nov 4, 2008·HIV Clinical Trials·Juan A PinedaUNKNOWN Fosamprenavir Expanded Access Program Group
Jan 2, 2007·HIV Clinical Trials·Rituparna P BasuAmgad F Helmy
Apr 13, 2011·British Journal of Clinical Pharmacology·Mas Chaponda, Munir Pirmohamed
Feb 17, 2007·Dermatitis : Contact, Atopic, Occupational, Drug·Daniel D Miller, Erin M Warshaw
Apr 22, 2008·AIDS Patient Care and STDs·Rose Kim, John D Baxter

❮ Previous
Next ❯

Related Concepts

Related Feeds

Antivirals

Antivirals are medications that are used specifically for treating viral infections. Discover the latest research on antivirals here.

Antivirals (ASM)

Antivirals are medications that are used specifically for treating viral infections. Discover the latest research on antivirals here.