Abstract
This is an open-label, single-arm, phase 3b study (part of phase 3 development) to evaluate the efficacy and safety of Fortovase-soft gelatin formulation (saquinavir-SGC), combined with zidovudine (ZDV) and lamivudine (3TC), human immune deficiency virus type 1 in (HIV-1)-positive, antiretroviral-naive individuals. Forty-two HIV-1-positive adults with plasma HIV RNA >10,000 copies per milliliter (Roche Amplicor HIV Monitor assay) and CD4 cell count >100 cells/mm(3) were treated with SQV-SGC, 1200 mg three times per day; ZDV, 300 mg; and 3TC, 150 mg each twice per day for 48 weeks. High proportions were drug users (26%), demonstrated psychiatric disorders (alcohol abuse [14%]/depression [14%]), or were inadequately housed (5%). At 48 weeks, 50% of patients achieved viral suppression <400 copies per milliliter with 43% <20 copies per milliliter using an intent-to-treat analysis (missing values counted as virological failures). Corresponding proportions for patients remaining on therapy at 48 weeks were 91% <400 copies per milliliter and 78% <20 copies per milliliter. Most adverse events were mild. Saquinavir-SGC combined with ZDV and 3TC, achieved potent and durable HIV RNA suppression and was well tolerated over 48 weeks in an a...Continue Reading
References
Sep 21, 1995·The New England Journal of Medicine·R E ChaissonR D Moore
Aug 18, 1994·The New England Journal of Medicine·P G O'ConnorR S Schottenfeld
Jan 1, 1994·Intervirology·J CinatlB Weber
Jun 11, 1996·Proceedings of the National Academy of Sciences of the United States of America·L MoutouhD D Richman
Apr 1, 1997·The Nurse Practitioner·B D Klaus, M J Grodesky
Sep 11, 1997·The New England Journal of Medicine·S M HammerM A Fischl
Nov 21, 1997·Science·D FinziR F Siliciano
Dec 5, 1997·AIDS·S MehtaN M Graham
Feb 10, 1998·AIDS·L C KaldjianG Friedland
Aug 26, 1998·JAMA : the Journal of the American Medical Association·D D CelentanoR D Moore
Aug 26, 1998·JAMA : the Journal of the American Medical Association·S A StrathdeeR S Hogg
Aug 26, 1998·JAMA : the Journal of the American Medical Association·R Sherer
Aug 26, 1998·AIDS·M J Gill
Oct 13, 1998·Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology : Official Publication of the International Retrovirology Association·J Lalezari
Feb 12, 1999·Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology : Official Publication of the International Retrovirology Association·S Michaels, P Kissinger
Jul 9, 1999·AIDS·S G DeeksR M Grant
Jul 27, 1999·Annals of Internal Medicine·G M LucasR D Moore
Jan 27, 2000·JAMA : the Journal of the American Medical Association·C C CarpenterP A Volberding
May 12, 2000·AIDS·J J EronM S Shaefer
Jul 13, 2000·Reviews in Medical Virology·M Harris, J S Montaner
Citations
Sep 4, 2003·AIDS Patient Care and STDs·Joseph InunguReid Skeel
Jan 27, 2005·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Elise D RileyAndrew R Moss
Oct 21, 2006·AIDS·John A BartlettFranck Rousseau
Mar 12, 2004·Expert Opinion on Pharmacotherapy·Zelalem TemesgenUNKNOWN Collaborative Research Network (CORNET) Investigators