Durable HIV-1 suppression with indinavir after failing lamivudine-containing double nucleoside therapy: A randomized controlled trial

Antiviral Therapy

Volumn 6, Issue 1, 2001, Pages 55-62

  Foudraine, Norbert A ^a,b   Jurriaans, Suzanne ^b   Weverling, Gerrit Jan ^b   Burger, David M ^c   Hoetelmans, Richard M W ^d   Roos, Marijke T L ^e   Maas, Jaap ^a   Miedema, Frank ^e   Reiss, Peter ^b   Portegies, Peter ^b   De Wolf, Frank ^b   Lange, Joep M A ^b  

^a MUNICIPAL HEALTH SERVICE   (Netherlands)

^b UNIVERSITY OF AMSTERDAM   (Netherlands)

^c RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^d SLOTERVAART HOSPITAL   (Netherlands)

^e CENTRAL LABORATORY   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

INDINAVIR; LAMIVUDINE; VIRUS RNA; ZIDOVUDINE;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ADULT; ARTICLE; BLOOD; CD4 LYMPHOCYTE COUNT; CEREBROSPINAL FLUID; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG COMBINATION; DRUG EFFECT; FOLLOW UP; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; IMMUNOLOGY; MIDDLE AGED; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; VIROLOGY;

ACQUIRED IMMUNODEFICIENCY SYNDROME; ADULT; CD4 LYMPHOCYTE COUNT; DRUG THERAPY, COMBINATION; FOLLOW-UP STUDIES; HIV-1; HUMANS; INDINAVIR; LAMIVUDINE; MIDDLE AGED; PROSPECTIVE STUDIES; RNA, VIRAL; ZIDOVUDINE;

EID: 0035294405     PISSN: 13596535     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (43)

1. Gulick RM, Mellors JW, Havlir DV, Eron JJ, Gonzalez C, McMahon D, Richman DD, Valentine PT, Jonas L, Meibohm A, Emini EA & Chodakewitz JA. Treatment with indinavir, zidovudine, and lamivudine in adults with human immunodeficiency virus infection and prior antiretroviral therapy. New England Journal of Medicine 1997; 337:734-739.
2. Hammer SM, Squires KE, Hughes MD, Grimes JM, Demeter LM, Currier JS, Eron JJ, Feinberg JE, Balfour HH, Deyton LR, Chodakewitz JA & Fischl MA. A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. New England Journal of Medicine 1997; 337:725-733.
3. Montaner JSG, Reiss P, Cooper DA, Vella S, Harris M, Conway B, Wainberg MA, Smith D, Robinson P, Hall D, Myers M & Lange JMA. A randomized, double-blind trial comparing combinations of nevirapine, didanosine, and zidovudine for HIV-infected patients. Journal of the American Medical Association 1998; 279:930-937.
4. Palella FJ, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, Aschman DJ & Holmberg SD. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. New England Journal of Medicine 1998; 338:853-860.
5. Carpenter CCJ, Fischl MA, Hammer SM, Hirsch MS, Jacobsen DM, Katzenstein DA, Montener JSG, Richman DD, Saag MS, Schooley RT, Thompson MA, Vella S, Yeni PG & Volberding PA. Antiretroviral therapy for HIV infection in 1998. Journal of the American Medical Association 1998; 280:78-86.
6. Foudraine NA, De Jong JJ, Weverling GJ, van Benthern BHB, Maas J, Keet IPM, Jurrians S, Roos MTL, Vandermeulen K, de Wolf F & Lange JMA. An open randomised controlled trial of zidovudine (AZT) + lamivudine (3TC) versus stavudine (d4T) + lamivudine in antiretroviral therapy-naive patients infected with human immunodeficiency virus type 1. AIDS 1998; 12:1513-1519.
7. Mathez D, Bagnarelli P, Gorin I, Katlama C, Pialoux G, Saimot G, Tubiana P, de Truchis P, Chauvin J-P, Mills R, Rode R, Clementi M & Leibowitch J. Reductions in viral load and increases in T lymphocyte numbers in treatment-naive patients with advanced HIV-1 infection treated with ritonavir, zidovudine and zalcitabine triple therapy. Antiviral Therapy 1998; 2:175-183.
8. Cohen Stuart JW, Schuurman R, Burger DM, Koopmans PP, Sprenger HG, Juttmann JR, Richter C, Meenhorst PL, Hoetelmans RM, Kroon FP, Bravenboer B, Harmann D, Boucher CA & Borleffs JC. Randomized trial comparing saquinavir soft gelatin capsules versus indinavir as part of triple therapy (CHEESE study). AIDS 1999; 13:F53-F58.
9. Fron JJ Jr, Murphy RL, Peterson D, Pottage J, Parenti DM, Jemsek J, Swindells S, Sepulvoda G, Bellos N, Rashbaum BC, Esinhart J, Schoellkopf N, Grosso R & Stevens M. A comparison of stavudine, didanosine and indinavir with zidovudine, lamivudine and indinavir for the initial treatment of HIV-1 infected individuals: selection of thymidine analog regimen therapy (START II). AIDS 2000; 14:1601-1610.
10. Squires KE, Gulick R, Tebas P, Santana J, Mulanovich V, Clark R, Yangco B, Marlowe SI, Wright D, Cohen C, Cooley T, Mauney J, Uffelman K, Schoellkopf N, Grosso R & Stevens M. A comparison of stavudine plus lamivudine versus zidovudine plus lamivudine in combination with indinavir in antiretroviral naive individuals with HIV infection: selection of thymidine analog regimen therapy (START I). AIDS 2000; 14:1591-1600.
11. Kempf DJ, Rode RA, Xu Y, Sun E, Heath-Chiozzi ME, Valdes J, Japour AJ, Danner SA, Boucher C, Molla A & Leonard JM. The duration of viral suppression during protease inhibitor therapy for HIV-1 infection is predicted by plasma HIV-1 RNA at the nadir. AIDS 1998; 12:F9-F14.
12. Raboud JM, Montaner JSG, Conway B, Rac S, Reiss P, Vella S, Cooper DA, Lange JMA, Harris M, Wainberg M, Robinson P, Myers M & Hall D. Predictors of duration of plasma viral load suppression among HIV infected individuals receiving antirteroviral therapy. AIDS 1998; 12:1619-1624.
13. Foudraine NA, Hoetelmans R, Lange JMA, de Wolf F, can Benthem BHB, Maas J, Keet IPM & Portgies P. Cerebrospinal fluid (CSF) HIV-RNA and drug concentrations during treatment with lamivudine (3TC) in combination with zidovudine (AZT) or stavudine (d4T). Lancet 1998; 351:1547-1551.
14. Schockmel GA, Yerly S & Perrin L. Detection of low HIV-1 RNA levels in plasma. Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology 1997; 14:179-183.
15. Cornelissen M, van den Burg R, Zorgdrager F, Lukashov V & Goudsmit J. Pol gene diversity of five human immunodeficiency virus type 1subtypes: evidence for naturally occuring mutations that contribute to drug resistance, limited recombination patterns, and common ancestry for subtypes B and D. Journal of Virology 1997; 71:6348-6358.
16. Burger DM, de Graaf R, Wuis EW, Koopmans PP & Hekster YA. Determination of indinavir, an HIV-protease inhibitor, in human plasma by reserved-phase high-performance liquid chromatography. Journal of Chromatography 1997; 703:235-241.
17. Burger DM, Rosing H, van Gijn R, Meenhorst PL, van Tellingen O & Beijen JH. Determination of stavudine, a new antiretroviral agent, in human plasma by reversed-phase high-performance liquid chromatography with ultraviolet detection. Journal of Chromatography 1992; 584:239-247.
18. Burger DM, Meenhorst PL, Bult A & Beijnen JH. Evaluation of two immunoassays for the determination of zidovudine in biological matrices. Journal of Drug Development and Clinical Practice 1996; 7:313-318.
19. Harker AJ, Evans GL, Hawley AE & Morris DM. High-performance liquid chromatographic assay for 2′-deoxy-3′-thiacytidine in human serum. Journal of Chromatography 1994; 657:227-232.
20. Havlir DV, Marschner IC, Hirsch MS, Collier AC, Tebas P, Bassett RL, Ioannidis JP, Holohan MK, Leavitt R, Boone G & Richman DD. Maintenance antiretroviral therapies in HIV-infected subjects with undetectable plasma HIV RNA after triple-drug therapy. New England Journal of Medicine 1998; 339:1261-1268.
21. Pialoux G, Raffi F, Brun-Vezinet F, Meiffredy V, Frandre P, Gastaut JA, Dellamonica P, Yeni P, Delfraissy JF & Aboulker JP. A randomized trial of three maintenance regimens given after three months of induction therapy with zidovudine, lamivudine, and indinavir in previously untreated HIV-1-infected patients. New England Journal of Medicine 1998; 339:1269-1276.
22. Reijers MHE, Weverling GJ, Jurriaans S, Wit FWNM, Weigel HM, Ten Kate RW, Mulder JW, Frissen PHJ, Van Leeuwen R, Reiss P, Schuitemaker H, de Wolf F & Lange JMA. Maintenance therapy after quadruple induction therapy in HIV-1 infected individuals: Amsterdam duration of antiretroviral medication (ADAM) study. Lancet 1998; 352:185-190.
23. Farthing C, Sension M, Pilson R & Siemon-Hryczyk P. Fortovase (saquinavir) soft gel capsules in combination with AZT and 3TC in antiretroviral-naive HIV-1 infected patients. 12th World AIDS Conference, Geneva, Switzerland, 28 June - 3 July 1998. Abstr. 12301.
24. Melby T, Sortell S, Thorborn D, Cutrell A, Pearce G, Lafon S, Lafon S & Lanier ER. Comparison of Viral Resistance Emerging Over 48 Weeks of Therapy with IDV/COM vs. ABC/COM (CNA3005). 7th Conference on Retroviruses and Opportunistic Infections, San Francisco, Calif., USA, 30 January - 2 February 2000. Abstr. 750.
25. AVANTI 2 . Randomized, double-blind trial to evaluate the efficacy and safety of zidovudine plus lamivudine versus zidovudine plus lamivudine plus indinavir in HIV-infected antiretroviral-naive patients. AIDS 2000; 14:367-374.
26. Gulick RM, Mellors JW, Havlir DV, Eron JJ, Gonzalez C, McMahon D, Jonas L, Meibohm A, Holder D, Schleif W, Condra JH, Emini EA, Isaacs R, Chodukewitz JA & Richman DD. Simultaneous vs sequential initiation of therapy with indinavir, zidovudine, and lamivudine for HIV-1 infection. Journal of the American Medical Association 1998; 280:35-41.
27. Descamps D, Flandre P, Calvez VPeytavin G, Meiffredy V, Collin G, Delaugerre C, Robert-Delmas S, Bazin B, Aboulker JP, Pialoux G, Raffi F & Brun-Vezinet F. Mechanisms of virologic failure in previously untreated HIV-infected patients from a trial of induction-maintenance therapy. Trilege (Agence Nationale de Recherches sur le SIDA 072) Study Team). Journal of the American Medical Association 2000; 283:205-211.
28. Nijhuis M, Schuurman R, de Jong D, Van Leeuwen R, Lange J, Danner SA, Keulen W, de Groot T & Boucher CAB. Lamivudine-resistant human immunodeficiency virus type 1 variants (184V) require multiple amino acid changes to become co- resistant to zidovudine in vivo. Journal of Infectious Diseases 1997; 176:398-405.
29. Back NK, Nijhuis M, Keulen W, Boucher CA, Oude Essink BO, van Kuilenburg AB, van Gennip AH & Berkout B. Reduced replication of 3TC-resisrant HIV-1 variants in primary cells due to a processivity defect of the reverse transcriptase enzyme. European Molecular Biology Organization Journal 1996; 15:4040-4049.
30. Oude Essink BB, Back NK & Berkhout B. Increased polymerase fidelity of the 3TC-resistant variants of HIV-1 reverse transcriptase. Nucleic Acids Research 1997; 25:3212-3217.
31. Wainberg MA, Drosopoulos WC, Salomon H, Hsu M, Borkow G, Parniak MA, Gu Z, Song Q, Manne J, Islam S, Castriota G & Prasad VR. Enhanced fidelity of 3TC-selected mutant HIV-1 reverse transciptase. Science 1996; 271:1282-1285.
32. Keulen W, van Wijk A, Schuurman R, Berkhout B & Boucher CA. Increased polymerase fidelity of lamivudine-resistant HIV-1 variants does not limit their evolutionary potential. AIDS 1999; 13:1343-1349.
33. Jonckheere H, De Clercq E & Anne J. Fidelity analysis of HIV-1 reverse transcriptase mutants with an altered amino-acid sequence at residues Leu74, Glu89, Tyr115, Tyr183 and Met184. European Journal of Biochemistry 2000; 267:2658-2665.
34. Havlir DV, Hellmann NS, Petropoulos CJ, Whitcomb JM, Collier AC, Hirsch MS, Tobas P, Sommadossi JP & Richman DD. Drug susceptibility in HIV infection after viral rebound in patients receiving indinavir-containing regimens. Journal of the American Medical Association 2000; 283:229-234.
35. Hughes MD, Daniels MJ, Fischl MA, Kim S & Schooley RT. CD4 cell count as a surrogate endpoint in HIV clinical trials: a meta-analysis of studies of the AIDS Clinical Trials Group. AIDS 1998; 12:1823-1832.
36. Farthing C, Japour A, Cohen C, Cameron B, Follansbee S, Markowitz M, Mellors J, Poretz D, Ho D, Mahon DM, Berg J, Nieves J, Xu Y, Rode R, Salgo M, Leonard J & Sun E. Cerebrospinal fluid and plasma HIV-RNA suppression with ritonavir-saquinavir in protease inhibitor naive patients. ICAAC, 28 September - 1 October 1997, Toronto, Canada. Abstr. LB 3.
37. Gisolf EH, Enting RH, Jurriaans S, de Wolf F, van der Ende ME, Hoetelmans RM, Portegies P & Danner SA. Cerebrospinal fluid HIV-1 RNA during treatment with ritonavir/saquinavir or ritonavir/saquinavir/stavudine. AIDS 2000; 14:1583-1589.
38. van Praag RM, Weverling GJ, Portegies P, Jurriaans S, Zhou XJ, Turner-Foisy ML, Sommadossi JP, Burger DM, Lange JM, Hoetelmans RM & Prins JM. Enhanced penetration of indinavir in cerebrospinal fluid and semen after the addition of low-dose ritonavir. AIDS 2000; 14:1187-1194.
39. Brinkman K, Kroon F, Hugen PWN & Burger DM. Therapeutic concentrations of indinavir in cerebrospinal fluid of HIV-1-infected patients. AIDS 1998; 12:537-537.
40. Martin C, Sonnerborg A, Svensson JO & Stahle L. Indinavir-based treatment of HIV-1 infected patients: efficacy in the central nervous system. AIDS 1999; 13:1227-1232.
41. Stahle L, Martin C, Svensson J-O & Sönnerborg A. Indinavir in cerebrospinal fluid of HIV-1 infected patients. Lancet 1997; 350:1823.
42. Moyle GJ, Sadler M & Buss N. Plasma and cerebrospinal fluid saquinavir concentrations in patients receiving combination antiretroviral therapy. Clinical Infectious Diseases 1999; 28:403-404.
43. Kim RB, Fromm MF, Wandel C, Leake B, Wood AJ, Roden DM & Wilkinson GR. The drug transporter P-glycoprotein limits oral absorption and brain entry of HIV-1 protease inhibitors. Journal of Clinical Investigation 1998; 101:289-294.