TITLE

Efficacy and Safety of Emtricitabine vs Stavudine in Combination Therapy in Antiretroviral-Naive Patients: A Randomized Trial

AUTHOR(S)
Saag, Michael S.; Cahn, Pedro; Raffi, François; Wolff, Marcelo; Pearce, Daniel; Molina, Jean-Michel; Powderly, William; Shaw, Audrey L.; Mondou, Elsa; Hinkle, John; Borroto-Esoda, Katyna; Quinn, Joseph B.; Barry, David W.; Rousseau, Franck
PUB. DATE
July 2004
SOURCE
JAMA: Journal of the American Medical Association;7/14/2004, Vol. 292 Issue 2, p180
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Context Emtricitabine is a new, once-daily nucleoside reverse transcriptase inhibitor (NRTI) with potent activity against human immunodeficiency virus (HIV). Objective To assess the efficacy and safety of emtricitabine as compared with stavudine when used with a background regimen of didanosine and efavirenz. Design, Setting, and Patients Randomized, double-blind, double-dummy study conducted at 101 research clinics in North America, Latin America, and Europe. The first patient was enrolled on August 21, 2000; no investigator or patient was unblinded until the last patient randomized completed the week 48 visit on October 24, 2002. Analyses were based on data collected in a double-blind setting with a median follow-up of 60 weeks. Patients were 571 antiretroviral-naive, HIV-1–infected adults aged 18 years or older with viral load levels greater than or equal to 5000 copies/mL. Interventions Receipt of either 200 mg of emtricitabine once daily (plus stavudine placebo twice daily) (n = 286) or stavudine at standard doses twice daily (plus emtricitabine placebo once daily) (n = 285) plus open-label didanosine and efavirenz, once daily. Main Outcome Measure Persistent virological response, defined as achieving and maintaining viral load at or below the limit of assay quantification (≤400 or 50 copies/mL). Results At the interim analysis on June 14, 2002, when the last patient randomized completed 24 weeks of double-blind treatment (median follow-up time of 42 weeks), patients in the emtricitabine group had a higher probability of a persistent virological response ≤50 copies/mL vs the stavudine group (85% vs 76%, P = .005). This was associated with a higher mean CD4 cell count change from baseline for the emtricitabine group (156 cells/µL vs 119 cells/µL, P = .01 [of note, there was no statistical difference at 48 weeks {P = .15}, although a sensitivity analysis, using an intent-to-treat population with the last CD4 cell count observat...
ACCESSION #
13833490

 

Related Articles

  • Efficacy and Safety of Tenofovir DF vs Stavudine in Combination Therapy in Antiretroviral-Naive Patients: A 3-Year Randomized Trial. Gallant, Joel E.; Staszewski, Schlomo; Pozniak, Anton L.; DeJesus, Edwin; Suleiman, Jamal M. A. H.; Miller, Michael D.; Coakley, Dion F.; Lu, Biao; Toole, John J.; Cheng, Andrew K. // JAMA: Journal of the American Medical Association;7/14/2004, Vol. 292 Issue 2, p191 

    Context Tenofovir disoproxil fumarate (DF) is a once-daily nucleotide analogue reverse transcriptase inhibitor. Objective To evaluate the efficacy and safety of tenofovir DF compared with stavudine in antiretroviral-naive patients. Design, Setting, and Participants A prospective, randomized,...

  • Treatment of HIV/AIDS: Do the Dilemmas Only Increase? Sande, Merle A.; Ronald, Allan // JAMA: Journal of the American Medical Association;7/14/2004, Vol. 292 Issue 2, p266 

    Presents an editorial on HIV/AIDS treatment and mentions articles in this issue of "JAMA". Guidelines set by the International AIDS Society-USA (IAS-USA) for HIV care reported in this issue; View that clinical trials using highly active antiretroviral therapy (HAART) should be redirected to...

  • Treatment for Adult HIV Infection: 2004 Recommendations of the International AIDS Society-USA Panel. Yeni, Patrick G.; Hammer, Scott M.; Hirsch, Martin S.; Saag, Michael S.; Schechter, Mauro; Carpenter, Charles C. J.; Fischl, Margaret A.; Gatell, Jose M.; Gazzard, Brian G.; Jacobsen, Donna M.; Katzenstein, David A.; Montaner, Julio S. G.; Richman, Douglas D.; Schooley, Robert T.; Thompson, Melanie A.; Vella, Stefano; Volberding, Paul A. // JAMA: Journal of the American Medical Association;7/14/2004, Vol. 292 Issue 2, p251 

    Context Substantial changes in the field of human immunodeficiency virus (HIV) treatment have occurred in the last 2 years, prompting revision of the guidelines for antiretroviral management of adults with established HIV infection. Objective To update recommendations for physicians who provide...

  • Clinical Trials in Sub-Saharan Africa and Established Standards of Care: A Systematic Review of HIV, Tuberculosis, and Malaria Trials. Kent, David M.; Mwamburi, D. Mkaya; Bennish, Michael L.; Kupelnick, Bruce; Ioannidis, John P. A. // JAMA: Journal of the American Medical Association;7/14/2004, Vol. 292 Issue 2, p237 

    Context The minimum standard of care required for participants in clinical trials conducted in resource-poor settings is a matter of controversy; international documents offer contradictory guidance. Objective To determine whether recently published trials conducted in sub-Saharan Africa met...

  • Cohort Profile: Standardized Management of Antiretroviral Therapy Cohort (MASTER Cohort). Torti, Carlo; Raffetti, Elena; Donato, Francesco; Castelli, Francesco; Maggiolo, Franco; Angarano, Gioacchino; Mazzotta, Francesco; Gori, Andrea; Sighinolfi, Laura; Pan, Angelo; Cauda, Roberto; Scalzini, Alfredo; Quiros-Roldan, Eugenia; Nasta, Paola; Gregis, Giampietro; Benatti, Simone; Digiambenedetto, Simona; Ladisa, Nicoletta; Giralda, Mariarosaria; Saracino, Annalisa // International Journal of Epidemiology;Apr2017, Vol. 46 Issue 2, p1 

    No abstract available.

  • The Use of Pill Counts as a Facilitator of Adherence with Antiretroviral Therapy in Resource Limited Settings. Achieng, Loice; Musangi, Helen; Billingsley, Katherine; Onguit, Sharon; Ombegoh, Edwin; Bryant, LeeAnn; Mwiindi, Jonathan; Smith, Nathaniel; Keiser, Philip // PLoS ONE;Dec2013, Vol. 8 Issue 12, p1 

    Background:Pill counts are often used to measure adherence to ART, but there is little data on how they affect adherence. We previously showed a bivariate relationship between clinicians counting pills and adherence in patients receiving HIV care in Kenya. We present a secondary analysis of the...

  • Inadvertent non-nucleoside reverse transcriptase inhibitor (NNRTI)-based antiretroviral therapy in dual HIV-1/2 and HIV-2 seropositive West Africans: a retrospective study. Sarfo, Fred S.; Bibby, David F.; Schwab, Uli; Appiah, Lambert T.; Clark, Duncan A.; Collini, Paul; Phillips, Richard; Green, Ingrid; Dittmar, Matthias T.; Chadwick, David R. // Journal of Antimicrobial Chemotherapy (JAC);Sep2009, Vol. 64 Issue 3, p667 

    The article analyzes the impact of non-nucleoside reverse transcriptase inhibitor (NNRTI)-based antiretroviral therapy (ART) in dual HIV-1/2 or HIV-2 seropositive individuals in terms of clinical outcomes, surrogate markers or resistance mutations. There was relatively good response from the...

  • The Rate of Viral Rebound after Attainment of an HIV Load <50 Copies/mL According to Specific Antiretroviral Drugs in Use: Results from a Multicenter Cohort Study. Smith, Colette J.; Phillips, Andrew N.; Hill, Teresa; Fisher, Martin; Gazzard, Brian; Porter, Kholoud; Gilson, Richard; Easterbrook, Philippa; Matthias, Ryanne; Scullard, George; Johnson, Margaret A.; Sabin, Caroline A. // Journal of Infectious Diseases;10/15/2005, Vol. 192 Issue 8, p1387 

    Background. Relatively few data are available on the association between the use of specific antiretroviral drugs and the rate of viral rebound in those attaining a viral load (VL) <50 copies/mL while receiving highly active antiretroviral therapy (HAART). Methods. Patients achieving a VL <50...

  • Anti-HIV-1 Activity of Weekly or Biweekly Treatment with Subcutaneous PRO 140, a CCR5 Monoclonal Antibody. Jacobson, Jeffrey M.; Thompson, Melanie A.; Lalezari, Jacob P.; Saag, Michael S.; Zingman, Barry S.; D'Ambrosio, Paul; Stambler, Nancy; Rotshteyn, Yakov; Marozsan, Andre J.; Maddon, Paul J.; Morris, Stephen A.; Olson, William C. // Journal of Infectious Diseases;5/15/2010, Vol. 201 Issue 10, p1481 

    Background. PRO 140 is a humanized CCR5 monoclonal antibody that has demonstrated potent antiviral activity when it is administered intravenously to adults infected with CCR5-tropic (R5) human immunodeficiency virus type 1 (HIV-1). This study is the first to evaluate subcutaneous administration....

Share

Read the Article

Courtesy of THE LIBRARY OF VIRGINIA

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics