Efficacy and safety of tenofovir double-dose in treatment-experienced HIV-infected patients: The TENOPLUS study

Journal of Medical Virology

Volumn 79, Issue 2, 2007, Pages 105-110

  Dominguez, Stephanie ^a   Ghosn, Jade ^a   Peytavin, Gilles ^b   Izzedine, Hassan ^a   Wirden, Marc ^a   Ktorza, Nadine ^a   Miller, Michael ^c   Aubron Olivier, Camille ^a,c   Trylesinski, Aldo ^c   Calvez, Vincent ^a   Deray, Gilbert ^a   Katlama, Christine ^a  

^a PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^b BICHAT HOSPITAL   (France)

^c Gilead Sciences   (France)

Author keywords

HIV; Nucleotide reverse transcriptase inhibitors; Pharmacokinetic; Resistance; Tenofovir; Thymidine analogue associated mutations

Indexed keywords

AMPRENAVIR; ANTIRETROVIRUS AGENT; CD4 ANTIGEN; DIDANOSINE; LAMIVUDINE; NUCLEOSIDE ANALOG; RITONAVIR; TENOFOVIR;

ADD ON THERAPY; ADULT; ANTIVIRAL THERAPY; ARTICLE; CLINICAL ARTICLE; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; DRUG SCREENING; DRUG SENSITIVITY; ENZYME BLOOD LEVEL; FANCONI ANEMIA; FEMALE; GENE MUTATION; GLUCOSURIA; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPOPHOSPHATEMIA; LOW DRUG DOSE; MALE; PILOT STUDY; PLASMA; PROTEIN BLOOD LEVEL; PROTEINURIA; RETROVIRUS; RETROVIRUS INFECTION; SIDE EFFECT; THYMIDINE ASSOCIATED RESISTANCE MUTATION; VIRUS LOAD; VIRUS REPLICATION; VIRUS RESISTANCE; VIRUS STRAIN;

ADENINE; ADULT; ANTI-HIV AGENTS; CD4 LYMPHOCYTE COUNT; DRUG RESISTANCE, VIRAL; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; MALE; MIDDLE AGED; MUTATION; PHOSPHONIC ACIDS; PILOT PROJECTS; REVERSE TRANSCRIPTASE INHIBITORS; RNA, VIRAL; VIRAL LOAD;

EID: 33846006175     PISSN: 01466615     EISSN: 10969071     Source Type: Journal    
DOI: 10.1002/jmv.20769     Document Type: Article

References (28)

1. Barditch-Crovo P, Deeks SG, Collier A, Safrin S, Coakley DF, Miller M, Kearney BP, Coleman RL, Lamy PD, Kahn JO, McGowan I, Lietman PS. 2001. Phase i/ii trial of the pharmacokinetics, safety, and antiretroviral activity of tenofovir disoproxil fumarate in human immunodeficiency virus-infected adults. Antimicrob Agents Chemother 45:2733-2739.
2. Creput C, Gonzalez-Canali G, Hill G, Piketty C, Kazatchkine M, Nochy D. 2003. Renal lesions in HIV-1-positive patient treated with tenofovir. AIDS 17:935-937.
3. Cundy KC, Sueoka C, Lynch GR, Griffin L, Lee WA, Shaw JP. 1998. Pharmacokinetics and bioavailability of the anti-human immunodeficiency virus nucleotide analog 9-[(R)-2-(phosphonomethoxy)-propyl]adenine (PMPA) in dogs. Antimicrob Agents Chemother 42: 687-690.
4. Gallant J, Parish M, Keruly J, Moore M. 2005. Decline in renal function associate with tenofovir DF compared with nucleoside reverse transcriptase inhibitors. Boston, USA.
5. Hirsch MS, Brun-Vezinet F, Clotet B, Conway B, Kuritzkes DR, D'Aquila RT, Demeter LM, Hammer SM, Johnson VA, Loveday C, Mellors JW, Jacobsen DM, Richman DD. 2003. Antiretroviral drug resistance testing in adults infected with human immunodeficiency virus type 1: 2003 recommendations of an International AIDS Society-USA Panel. Clin Infect Dis 37:113-128.
6. Izzedine H, Launay-Vacher V, Isnard-Bagnis C, Deray G. 2003. Drug-induced Fanconi's syndrome. Am J Kidney Dis 41:292-309.
7. Izzedine H, Isnard-Bagnis C, Hulot JS, Vittecoq D, Cheng A, Jais CK, Launay-Vacher V, Deray G. 2004. Renal safety of tenofovir in HIV treatment-experienced patients. AIDS 18:1074-1076.
8. Karras A, Lafaurie M, Furco A, Bourgarit A, Droz D, Sereni D, Legendre C, Martinez F, Molina JM. 2003. Tenofovir-related nephrotoxicity in human immunodeficiency virus-infected patients: Three cases of renal failure, Fanconi syndrome, and nephrogenic diabetes insipidus. Clin Infect Dis 36:1070-1073.
9. Katlama C, Clotet B, Plettenberg A, Jost J, Arasteh K, Bernasconi E, Jeantils V, Cutrell A, Stone C, Ait-Khaled M, Purdon S. 2000. The role of abacavir (ABC, 1592) in antiretroviral therapy-experienced patients: Results from a randomized, double-blind, trial. CNA3002 European Study Team. AIDS 14:781-789.
10. Katlama C, Clotet B, Plettenberg A, Jost J, Arasteh K, Bernasconi E, Jeantils V, Cutrell A, Stone C, Purdon S. 2001. Intensification of stable background therapy with abacavir in antiretroviral therapy experienced patients: 48-week data from a randomized, double-blind trial. HIV Med 2:27-34.
11. Katlama C, Dominguez S, Gourlain K, Duvivier C, Delaugerre C, Legrand M, Tubiana R, Reynes J, Molina JM, Peytavin G, Calvez V, Costagliola D. 2004a. Benefit of treatment interruption in HIV-infected patients with multiple therapeutic failures: A randomized controlled trial (ANRS 097). AIDS 18:217-226.
12. Katlama C, Ghosn J, Tubiana R, Wirden M, Valantin MA, Harmenberg J, Mardh G, Oberg B, Calvez V. 2004b. MIV-310 reduces HIV viral load in patients failing multiple antiretroviral therapy: Results from a 4-week phase II study. AIDS 18:1299-1304.
13. Kearney BP, Flaherty JF, Shah J. 2004. Tenofovir disoproxil fumarate: Clinical pharmacology and pharmacokinetics. Clin Pharmacokinet 43:595-612.
14. Marcelin AG, Lamotte C, Delaugerre C, Ktorza N, Ait Mohand H, Cacace R, Bonmarchand M, Wirden M, Simon A, Bossi P, Bricaire F, Costagliola D, Katlama C, Peytavin G, Calvez V. 2003. Genotypic inhibitory quotient as predictor of virological response to ritonavir-amprenavir in human immunodeficiency virus type 1 protease inhibitor-experienced patients. Antimicrob Agents Chemother 47: 594-600.
15. Margot NA, Isaacson E, McGowan I, Cheng AK, Schooley RT, Miller MD. 2002. Genotypic and phenotypic analyses of HIV-1 in antiretroviral-experienced patients treated with tenofovir DF. AIDS 16:1227-1235.
16. Masquelier B, Tamalet C, Montés B, Descamps D, Peytavin G, Bocket L, Wirden M, Izopet J, Schneider V, Ferré V, Ruffault A, Palmer P, Trylisinski A, Miller M, Brun-Vezinet F. 2003. Gentypic determinants of the virological response to tenofovir in NRTI-experienced patients. Antivir Ther 8:S415
17. Miller MD, Margot N, Lu B, Zhong L, Chen SS, Cheng A, Wulfsohn M. 2004. Genotypic and phenotypic predictors of the magnitude of response to tenofovir disoproxil fumarate treatment in antiretroviral-experienced patients. J Infect Dis 189:837-846.
18. Molina JM, Marcelin AG, Pavie J, Heripret L, De Boever CM, Troccaz M, Leleu G, Calvez V. 2005. Didanosine in HIV-1-infected patients experiencing failure of antiretroviral therapy: A randomized placebo-controlled trial. J Infect Dis 191:840-847.
19. Nijhuis M, Boucher CA, Schipper P, Leitner T, Schuurman R, Albert J. 1998. Stochastic processes strongly influence HIV-1 evolution during suboptimal protease-inhibitor therapy. Proc Natl Acad Sci USA 95:14441-14446.
20. Richman DD, Morton SC, Wrin T, Hellmann N, Berry S, Shapiro MF, Bozzette SA. 2004. The prevalence of antiretroviral drug resistance in the United States. AIDS 18:1393-1401.
21. Robbins BL, Srinivas RV, Kim C, Bischofberger N, Fridland A. 1998. Anti-human immunodeficiency virus activity and cellular metabolism of a potential prodrug of the acyclic nucleoside phosphonate 9-R-(2- phosphonomethoxypropyl)adenine (PMPA), Bis(isopropyloxymethylcarbonyl)PMPA. Antimicrob Agents Chemother 42:612-617.
22. Rollot F, Nazal EM, Chauvelot-Moachon L, Kelaidi C, Daniel N, Saba M, Abad S, Blanche P. 2003. Tenofovir-related Fanconi syndrome with nephrogenic diabetes insipidus in a patient with acquired immunodeficiency syndrome: The role of lopinavir-ritonavirdidanosine. Clin Infect Dis 37:e174-176.
23. Schooley RT, Ruane P, Myers RA, Beall G, Lampiris H, Berger D, Chen SS, Miller MD, Isaacson E, Cheng AK. 2002. Tenofovir DF in antiretroviral- experienced patients: Results from a 48-week, randomized, double-blind study. AIDS 16:1257-1263.
24. Squires K, Pozniak AL, Pierone G, Jr., Steinhart CR, Berger D, Bellos NC, Becker SL, Wulfsohn M, Miller MD, Toole JJ, Coakley DF, Cheng A. 2003. Tenofovir disoproxil fumarate in nucleoside-resistant HIV-1 infection: A randomized trial. Ann Intern Med 139:313-320.
25. Srinivas RV, Fridland A. 1998. Antiviral activities of 9-R-2-phosphonomethoxypropyl adenine (PMPA) and bis(isopropyloxymethylcarbonyl) PMPA against various drug-resistant human immunodeficiency virus strains. Antimicrob Agents Chemother 42:1484-1487.
26. Verhelst D, Monge M, Meynard JL, Fouqueray B, Mougenot B, Girard PM, Ronco P, Rossert J. 2002. Fanconi syndrome and renal failure induced by tenofovir: A first case report. Am J Kidnev Dis 40:1331-1333.
27. Wainberg MA, Miller MD, Quan Y, Salomon H, Mulato AS, Lamy PD, Margot NA, Anton KE, Cherrington JM. 1999. In vitro selection and characterization of HIV-1 with reduced susceptibility to PMPA. Antivir Ther 4:87-94.
28. Wirden M, Malet I, Derache A, Marcelin AG, Roquebert B, Simon A, Kirstetter M, Joubert LM, Katlama C, Calvez V. 2005. Clonal analyses of HIV quasispecies in patients harbouring plasma genotype with K65R mutation associated with thymidine analogue mutations or L74V substitution. AIDS 19: 630-632.