Pharmacokinetic interaction between nelfinavir and pravastatin in HIV-seronegative volunteers: ACTG Study A5108

AIDS

Volumn 20, Issue 5, 2006, Pages 725-729

  Aberg, Judith A ^a   Rosenkranz, Susan L ^b   Fichtenbaum, Carl J ^c   Alston, Beverly L ^d   Brobst, Susan W ^e   Segal, Yoninah ^b   Gerber, John G ^f  

^a NEW YORK UNIVERSITY   (United States)

^b HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^c UNIVERSITY OF CINCINNATI   (United States)

^d NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^e SOCIAL AND SCIENTIFIC SYSTEMS INC   (United States)

^f UNIVERSITY OF COLORADO   (United States)

Author keywords

Drug interactions; HIV infection; Nelfinavir; Pravastatin; Statins

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CREATINE KINASE; LOW DENSITY LIPOPROTEIN CHOLESTEROL; NELFINAVIR; PRAVASTATIN;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; BLOOD SAMPLING; CALCULATION; CHOLESTEROL BLOOD LEVEL; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; DOSE TIME EFFECT RELATION; DRUG ANTAGONISM; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG ERUPTION; DRUG RESEARCH; DYSLIPIDEMIA; FEMALE; GASTROINTESTINAL SYMPTOM; GILBERT DISEASE; HUMAN; MALE; MEDICAL RECORD; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL;

ADULT; AREA UNDER CURVE; DRUG ADMINISTRATION SCHEDULE; DRUG INTERACTIONS; FEMALE; HIV PROTEASE INHIBITORS; HIV SERONEGATIVITY; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; NELFINAVIR; PRAVASTATIN; TIME FACTORS; VOLUNTARY WORKERS;

EID: 33745094068     PISSN: 02699370     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.aids.0000216373.53819.92     Document Type: Article

References (20)

1. Bardsley-Elliot A, Plosker GL. Nelfinavir: an update on its use in HIV infection. Drugs 2000; 59:581-620.
2. Fichtenbaum CJ, Gerber JG, Rosenkranz SL, Segal Y, Aberg JA, Blaschke T, for the ACTG 5047 Study Team. Pharmacokinetic interactions between protease inhibitors and statins in HIV seronegative volunteers: ACTG Study A5047. AIDS 2002; 16:569-577.
3. Hsyu PH, Schultz-Smith MD, Lillibridge JH, Lewis RH, Kerr BM. Pharmacokinetic interactions between nelfinavir and 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors atorvastatin and simvastatin. Antimicrob Agents Chemother 2001; 45:3445-3450.
4. Gerber JG, Rosenkranz SL, Fichtenbaum CJ, Vega JM, Yang A, Alston BL, et al. Effect of efavirenz on the pharmacokinetics of simvastatin, atorvastatin, and pravastatin: results of AIDS Clinical Trials Group 5108 Study. J Acquir Immun Defic Syndr 2005; 39:307-312.
5. Yeh KC, Kwan KC. A comparison of numerical integrating algorithms by trapezoidal, Lagrange, and spline approximation. J Pharmacokinet Biopharm 1978; 6:79-98.
6. Bergmann R, Ludbrook J, Spooren WPJM. Different outcomes of the Wilcoxon-Mann-Whitney test from different statistics packages. Am Stat 2000; 54:72-77.
7. Jamal SM, Eisenberg MJ, Christopoulos S. Rhabdomyolysis associated with hydroxymethylglutaryl-coenzyme A reductase inhibitors. Am Heart J 2004; 147:956-965.
8. Center for Drug Evaluation and Research. FDA Guidance for Industry. Statistical Approaches to Establishing Bioequivalence. Washington, DC: US Department of Health and Human Services, Food and Drug Administration; 2001.
9. Cespedes MS, Aberg JA. Cardiovascular and endothelial disease in HIV infection. Curr Infect Dis Rep 2005; 7:309-315.
10. Dubé MP, Stein JH, Aberg JA, Fichtenbaum CJ, Gerber JG, Tashima KT, et al. Guidelines for the evaluation and management of dyslipidemia in human immunodeficiency virus (HIV)-infected adults receiving antiretroviral therapy: recommendations of the HIV Medical Association of the Infectious Disease Society of America and the Adult AIDS Clinical Trials Group. Clin Infect Dis 2003; 37:613-627.
11. Simonson SG, Raza A, Martin PD, Mitchell PD, Jarcho JA, Brown CD, et al. Rosuvastatin pharmacokinectics in heart transplant recipients administered an antirejection regimen including cyclosporine. Clin Pharmacol Ther 2004; 76:167-177.
12. Nishizato Y, Ieiri I, Suzuki H, Kimura M, Kawabata K, Hirota T, et al. Polymorphism of OATP-C (SLC21A6) and OAT3 (SLC22A8) genes: Consequences for pravastatin pharmacokinetics. Clin Pharmacol Ther 2003; 73:554-565.
13. Chung JY, Cho JY, Yu KS, Kim JR, Oh DS, Jung HR, et al. Effect of OATP1B1 (SLCO1B1) variant alleles on the pharmacokinetics of pitavastatin in healthy volunteers. Clin Pharmacol Ther 2005; 78:342-350.
14. Kyrklund C, Backman JT, Neuvonen M, Neuvonen PJ. Effect of rifampicin on pravastatin pharmacokinetics in healthy subjects. Br J Clin Pharmacol 2004; 57:181-187.
15. Jacobson TA. Comparative pharmacokinetic interaction profiles of pravastatin, simvastatin, and atorvastatin when coadministered with cytochrome P450 inhibitors. Am J Cardiol 2004; 94:1140-1146.
16. Kyrklund C, Backman JT, Neuvonen M, Neuvonen PJ. Gemfibrozil increases plasma pravastatin concentrations and reduces pravastatin renal clearance. Clin Pharmacol Ther 2003; 73:538-544.
17. Hedman M, Neuvonen PJ, Neuvonen M, Holmberg C, Antikainen M. Pharmacokinetics and pharmacodynamics of pravastatin in pediatric and adolescent cardiac transplant recipients on a regimen of triple immunosuppression. Clin Pharmacol Ther 2004; 75:101-109.
18. Aberg JA, Zackin RA, Brobst SW, Evans SR, Alston BL, Henry WK, for the ACTG 5087 team. A randomized trial comparing the efficacy and safety of fenofibrate versus pravastatin in HIV-infected subjects with lipid abnormalities: AIDS Clinical Trials Group Study 5087. AIDS Res Hum Retroviruses 2005; 21:757-767.
19. Calza L, Manfredi R, Colangeli V, Tampellini L, Sebastiani T, Pocaterra D, et al. Substitution of nevirapine or efavirenz for protease inhibitor versus lipid-lowering therapy for the management of dyslipidaemia. AIDS 2005; 19:1051-1058.
20. Benesic A, Zilly M, Kluge F, Weissbrich B, Winzer R, Klinker H, et al. Lipid lowering therapy with fluvastatin and pravastatin in patients with HIV infection and antiretroviral therapy: comparison of efficacy and interaction with indinavir. Infection 2004; 32:229-233.