Pharmacokinetics of and short-term virologic response to low-dose 400-milligram once-daily raltegravir maintenance therapy

Antimicrobial Agents and Chemotherapy

Volumn 56, Issue 4, 2012, Pages 1892-1898

  Ananworanich, Jintanat ^a,b,c   Gorowara, Meena ^a   Avihingsanon, Anchalee ^a,b   Kerr, Stephen J ^a,c   Van Heesch, Nadine ^d,e   Khongpetch, Chuleeporn ^a   Uanithirat, Anuntaya ^a   Hill, Andrew ^f   Ruxrungtham, Kiat ^a,b   Burgerf, David M ^e  

^a THAI RED CROSS AIDS RESEARCH CENTRE   (Thailand)

^b CHULALONGKORN UNIVERSITY   (Thailand)

^c UNIVERSITY OF NEW SOUTH WALES   (Australia)

^d UTRECHT UNIVERSITY   (Netherlands)

^e RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^f UNIVERSITY OF LIVERPOOL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ATAZANAVIR; CHOLESTEROL; DARUNAVIR PLUS RITONAVIR; HEMOGLOBIN; HIGH DENSITY LIPOPROTEIN; LAMIVUDINE; LOPINAVIR PLUS RITONAVIR; RALTEGRAVIR; TENOFOVIR; TRIACYLGLYCEROL; VIRUS RNA;

ADULT; AREA UNDER THE CURVE; ARTICLE; BODY WEIGHT; CD4 LYMPHOCYTE COUNT; CHOLESTEROL BLOOD LEVEL; CLINICAL ARTICLE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE CLEARANCE; CROSSOVER PROCEDURE; DOSAGE SCHEDULE COMPARISON; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE COMPARISON; DRUG HALF LIFE; DRUG MONITORING; FEMALE; HEMOGLOBIN BLOOD LEVEL; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LOW DRUG DOSE; MAINTENANCE THERAPY; MALE; MAXIMUM PLASMA CONCENTRATION; OPEN STUDY; OUTCOME ASSESSMENT; PATIENT MONITORING; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; SIDE EFFECT; THAILAND; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; VIREMIA; VIRUS LOAD;

ADULT; AGE FACTORS; AGED; AREA UNDER CURVE; BODY WEIGHT; COHORT STUDIES; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HALF-LIFE; HIV INFECTIONS; HIV INTEGRASE INHIBITORS; HIV-1; HUMANS; LIKELIHOOD FUNCTIONS; MALE; MIDDLE AGED; PYRROLIDINONES; REGRESSION ANALYSIS; RNA, VIRAL; SOFTWARE; THAILAND; VIRAL LOAD;

EID: 84858661696     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.05694-11     Document Type: Article

References (24)

1. Ananworanich J, et al. 2004. Creation of a drug fund for post-clinical trial access to antiretrovirals. Lancet 364:101-102. (Pubitemid 38968631)
2. Autar RS, et al. 2005. Interindividual variability of once-daily ritonavir boosted saquinavir pharmacokinetics in Thai and UK patients. J. Antimicrob. Chemother. 56:908-913. (Pubitemid 41631916)
3. Avihingsanon A, et al. 2009. A low dose of ritonavir-boosted atazanavir provides adequate pharmacokinetic parameters in HIV-1-infected Thai adults. Clin. Pharmacol. Ther. 85:402- 408.
4. Cattaneo D, et al. 2010. Exposure-related effects of atazanavir on the pharmacokinetics of raltegravir in HIV-1-infected patients. Ther. Drug Monit. 32:782-786.
5. Cooper DA, et al. 2008. Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection. N. Engl. J. Med. 359:355-365.
6. Cressey TR, et al. 2006. Intensive pharmacokinetics of zidovudine 200 mg twice daily in HIV-1-infected patients weighing less than 60 kg on highly active antiretroviral therapy. J. Acquir. Immune Defic. Syndr. 42:387-389. (Pubitemid 44050023)
7. Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents. 10 January 2011. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. http://www .aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed 13 January 2011.
8. Eron JJ, Jr, et al. 2011. Raltegravir once daily or twice daily in previously untreated patients with HIV-1: a randomised, active-controlled, phase 3 non-inferiority trial. Lancet Infect. Dis. 11:907-915.
9. Freedberg KA, et al. 2001. The cost effectiveness of combination antiretroviral therapy for HIV disease. N. Engl. J. Med. 344:824-831. (Pubitemid 32222162)
10. Grinsztejn B, et al. 2007. Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial. Lancet 369:1261-1269. (Pubitemid 46553846)
11. Hill A, Ananworanich J, Calmy A. 2010. Dose optimisation: a strategy to improve tolerability and lower antiretroviral drug prices in low and middle income countries. Open Infect. Dis. J. 4:85-91.
12. Lennox JL, et al. 2009. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial. Lancet 374:796-806.
13. Manosuthi W, et al. 2005. Efavirenz levels and 24-week efficacy in HIV-infected patients with tuberculosis receiving highly active antiretroviral therapy and rifampicin. AIDS 19:1481-1486. (Pubitemid 41400693)
14. Markowitz M, et al. 2006. Antiretroviral activity, pharmacokinetics, and tolerability of MK-0518, a novel inhibitor of HIV-1 integrase, dosed as monotherapy for 10 days in treatment-naive HIV-1-infected individuals. J. Acquir. Immune Defic. Syndr. 43:509 -515.
15. Markowitz M, et al. 2007. Rapid and durable antiretroviral effect of the HIV-1 integrase inhibitor raltegravir as part of combination therapy in treatment-naive patients with HIV-1 infection: results of a 48-week controlled study. J. Acquir. Immune Defic. Syndr. 46:125-133. (Pubitemid 47482607)
16. Neely M, et al2010. Pharmacokinetics and pharmacogenomics of oncedaily raltegravir and atazanavir in healthy volunteers. Antimicrob. Agents Chemother. 54:4619-4625.
17. Ramautarsing R, Ananworanich J. 2010. Generic and low dose antiretroviral therapy in adults and children: implication for scaling up treatment in resource limited settings. AIDS Res. Ther. 7:18.
18. Ribaudo H, et al. 2009. Virologic failure endpoint definition in clinical trials: is using HIV-1 RNA threshold <200 copies/mL better than <50 copies/mL? An analysis of ACTG studies, abstr 580. Sixteenth Conf. Retrovir. Opportun. Infect., 8 to 11 February 2009, Montreal, Canada.
19. Steigbigel RT, et al. 2008. Raltegravir with optimized background therapy for resistant HIV-1 infection. N. Engl. J. Med. 359:339 -354.
20. Steigbigel RT, et al. 2010. Long-term efficacy and safety of raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 phase III trials. Clin. Infect. Dis. 50:605-612.
21. Thompson MA, et al. 2010. Antiretroviral treatment of adult HIV infection: 2010 recommendations of the International AIDS Society-USA panel. JAMA 304:321-333.
22. van Luin M, et al. 2009. The effect of raltegravir on the glucuronidation of lamotrigine. J. Clin. Pharmacol. 49:1220 -1227.
23. Wenning L, et al. 2011. Pharmacokinetic/PD analyses for QDMRK, a phase III study of the safety and efficacy of once versus twice daily raltegravir in treatment-naïve patients, abstr O-09. Twelfth Int. Workshop Clin. Pharmacol. HIV Ther., Miami, FL, 13 to 15 April 2011.
24. Wenning LA, et al. 2008. Lack of a significant drug interaction between raltegravir and tenofovir. Antimicrob. Agents Chemother. 52:3253-3258.