Similar 96-week Renal Safety Profile of Tenofovir Disoproxil Fumarate (TDF) versus Stavudine (d4T) when used in Combination with Lamivudine (3TC) and Efavirenz (EFV) in Antiretroviral Naïve Patients JE Gallant1, AL Pozniak2, S Staszewski3, B Lu4, J Sayre4 and A Cheng4 for the Study 903 Team 1Johns Hopkins Univ School of Medicine, Baltimore, MD, USA; 2 Chelsea and Westminster Hosp, London, UK; 3University Hospital, J.W. Goethe-Universität, Frankfurt, Germany; 4Gilead Sciences, Foster City, CA, USA. 43rd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy September 14-17, 2003 Chicago, Illinois Poster No. H- 840 Background
Study 903 is an ongoing 144 week, randomized,double-blind, international multicenter trial whichcompares TDF and d4T when used in combinationwith EFV and 3TC in antiretroviral treatment naïvepatients.
Case reports of renal dysfunction have recentlybeen published1-6
Main Inclusion Criteria
• HIV-1 infected patients naïve to antiretroviral treatment• 18 - 65 years of age• Plasma HIV RNA > 5,000 copies/mL• No significant laboratory or clinical abnormalities• No CD4+ cell count criteria• Serum Creatinine < 1.5 mg/dL• Serum Phosphorus ≥ 2.2 mg/dL• Calculated Creatinine Clearance ≥ 60 mL/min
Study Design: Randomization ART-naive d4T placebo BID patients Stratification by:
• plasma HIV RNA >/< 100,000 c/ml
• CD4 count >/< 200 cells/mm³ randomized TDF placebo QD Baseline Characteristics TDF + 3TC + EFV d4T + 3TC + EFV Serum Creatinine Maximum Toxicity Grade TDF + 3TC + EFV d4T + 3TC + EFV 0-96 Weeks in mg/dL Consecutive Visits with Graded Creatinine TDF+3TC+EFV d4T+3TC+EFV Pat of er b m Consecutive Visits Serum Phosphorus Maximum Toxicity Grade TDF + 3TC + EFV d4T + 3TC + EFV 0-96 Weeks in mg/dL Consecutive Visits with Graded Serum Phosphorus TDF+3TC+EFV d4T+3TC+EFV tien a f P 10 Consecutive Visits Proteinuria Maximum Toxicity Grade TDF + 3TC + EFV d4T + 3TC + EFV 0-96 Weeks in mg/dL Glucosuria Maximum Toxicity Grade TDF + 3TC + EFV d4T + 3TC + EFV 0-96 Weeks in mg/dL Mean Increase from Baseline in Calculated Creatinine Clearance (Calc Cr Cl) TDF + 3TC + EFV d4T + 3TC + EFV Summary of Results: Parameters through 96 weeks Parameters through 96 weeks TDF+3TC+EFV d4T+3TC+EFV
Mean Change from Baseline inCalc Cr Cl* (mL/min)
Conclusions
• The renal safety profile was similar between the patients receiving tenofovir DF or stavudine plus lamivudine and efavirenz through 96 weeks
• No patients discontinued study due to tenofovir DF-related renal abnormalities
• No patient developed Fanconi’s Syndrome through 96 weeks References
1Blick G, et al. 10th CROI, Boston, MA, February 10-14, 2003. Poster 718
2Reynes J, et al. 10th CROI, Boston, MA, February 10-14, 2003. Poster 717
5Murphy MD, et al. CID 2003; 36:1082-1085
6Shere-Wolfe KD, et al. CID 2002; 35:1137
ORIGINAL CONTRIBUTION Osteopathic Manipulative Treatment in the Emergency Department for Patients With Acute Ankle Injuries Anita W. Eisenhart, DOTheodore J. Gaeta, DO, MPHDavid P. Yens, PhD Study Objective : The purpose of this study was to evaluate pression dressings, elevation of the affected ankle, analgesia the efficacy of osteopathic manipulative treatment (OMT) (specifically
Raving about Rhodiola (Rhodiola rosea) Rhodiola wasn’t an herb I was taught in herbal college, thus it is a fairly new addition to my dispensary cupboard. Yet, the more I learned about this herb, the more I had to have it! Its potential for my clients is too great not to!Rhodiola (Rhodiola rosea), also known as Stonecrop, Roseroot or Golden Root, among other names, is a member of the fami