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

被引：0

作者：

Gartland, M ^{[1
]}

Gerstoft, J ^{[1
]}

Goebel, F ^{[1
]}

Clumeck, N ^{[1
]}

Cooper, DA ^{[1
]}

Gatell, J ^{[1
]}

Gazzard, B ^{[1
]}

Gerstoft, J ^{[1
]}

Goebel, F ^{[1
]}

Lange, J ^{[1
]}

Montaner, J ^{[1
]}

Reiss, P ^{[1
]}

Rozenbaum, W ^{[1
]}

Vella, S ^{[1
]}

Beveridge, A ^{[1
]}

Cooper, DA ^{[1
]}

Duncombe, C ^{[1
]}

Gold, J ^{[1
]}

Haberl, M ^{[1
]}

Clumeck, N ^{[1
]}

Luyts, D ^{[1
]}

Montaner, J ^{[1
]}

Rachlis, A ^{[1
]}

Marina, R ^{[1
]}

Gerstoft, J ^{[1
]}

Wandall, JH ^{[1
]}

Elbrond, B ^{[1
]}

Molina, JM ^{[1
]}

Pialloux, G ^{[1
]}

Rozenbaum, W ^{[1
]}

Beauvais, L ^{[1
]}

Goebel, FD ^{[1
]}

Staszewski, S ^{[1
]}

Bruns, I ^{[1
]}

Hug, M ^{[1
]}

Reiss, P ^{[1
]}

Lange, J ^{[1
]}

Frissen, PHJ ^{[1
]}

van der Ende, ME ^{[1
]}

Bosboom, M ^{[1
]}

Baas, C ^{[1
]}

Milazzo, F ^{[1
]}

Moroni, M ^{[1
]}

Panebianco, R ^{[1
]}

Clotet, B ^{[1
]}

Artigas, JMG ^{[1
]}

Gonzalez-Lahoz, J ^{[1
]}

Leal, M ^{[1
]}

Rodriguez-Lopo, C ^{[1
]}

Gandarias, B ^{[1
]}

机构：

[1] Glaxo Wellcome Res & Dev Ltd, Greenford UB6 0HE, Middx, England

来源：

AIDS | 2000年 / 14卷 / 04期

关键词：

antiretroviral therapy; clinical trials; combination therapy; protease inhibitors; reverse transcriptase inhibitors;

D O I：

暂无

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Objectives: To investigate the effect of combination antiretroviral therapy on plasma HIV-1 RNA as measured by HIV RNA PCR and to assess their safety and tolerability. Design: A randomized, multicentre, double-blind, placebo-controlled trial. Setting: Multicentre study in eight European countries, Australia and Canada. Patients: Antiretroviral naive patients (n = 103) with CD4 cell counts between 150 and 500 x 10(6)/I. Intervention: Patients were randomly assigned to zidovudine (ZDV; 200 mg three times per day) plus lamivudine (3TC; 150mg twice per day) or to ZDV + 3TC + indinavir (IND; 800 mg q8h) for 52 weeks. Main outcome measures: Degree and duration of reduction of plasma HIV-1 RNA as measured by RNA PCR; Development of drug-related toxicities sufficiently severe to warrant dose modification, interruption or permanent discontinuation. Results: ZDV + 3TC + IND reduced plasma HIV-1 RNA (P < 0.001) and increased CD4 cell count significantly (P = 0101) more than ZDV + 3TC. The addition of IND to ZDV + 3TC as initial therapy markedly increased the proportion of patients with plasma HIV-1 RNA values 500 copies/ml (31/52, 60%) or 20 copies/ml (24/52, 46%) as compared with ZDV + 3TC (9/50, 18% or 2/50, 4% respectively) at week 52 in an intention-to-treat, missing = failure analysis. Assessment of time to virological rebound (> 0.5 log(10) copies/ml above nadir) showed that patients who attained a minimum plasma HIV-1 RNA of less than or equal to 20 copies/ml were less likely to rebound than those who did not reach this threshold. The addition of IND to ZDV + 3TC did not result in any significant increase in adverse experiences. Conclusion: ZDV + 3TC + IND resulted in a considerable improvement compared with the double combination, in reduction in plasma HIV-1 RNA, increase in CD4 cell count and proportion of patients with HIV RNA below the limit of detection. Despite an average 3 log(10) decrease in plasma HIV-1 RNA on triple therapy, however, maximal suppression (less than or equal to 20 copies/ml) was only attained in about one-half of the patients in an intent-to-treat analysis. (C) 2000 Lippincott Williams & Wilkins

引用

页码：367 / 374

页数：8

共 50 条

[1] AVANTI 1: randomized, double-blind trial to evaluate the efficacy and safety of zidovudine plus lamivudine versus zidovudine plus lamivudine plus loviride in HIV-infected antiretroviral-naive patients
Gatell, J
Lange, J
Gartland, M
[J]. ANTIVIRAL THERAPY, 1999, 4 (02) : 79 - 86
[2] AVANTI 3: a randomized, double-blind trial to compare the efficacy and safety of lamivudine plus zidovudine versus lamivudine plus zidovudine plus nelfinavir in HIV-1-infected antiretroviral-naive patients
Gartland, M
[J]. ANTIVIRAL THERAPY, 2001, 6 (02) : 127 - 134
[3] A randomized, open-label, comparative trial of zidovudine plus lamivudine versus zidovudine plus lamivudine plus didanosine in antiretroviral-naive HIV-1-infected Thai patients
Ungsedhapand, C
Kroon, EDMB
Suwanagool, S
Ruxrungtham, K
Yimsuan, N
Sonjai, A
Ubolyam, S
Buranapraditkun, S
Tiengrim, S
Pakker, N
Kunanusont, C
Lange, JMA
Cooper, DA
Phanuphak, P
[J]. JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES, 2001, 27 (02) : 116 - 123
[4] Lopinavir/ritonavir monotherapy or plus zidovudine and lamivudine in antiretroviral-naive HIV-infected patients
Delfraissy, Jean-Fran Ois
Flandre, Philippe
Delaugerre, Constance
Ghosn, Jade
Horban, Andrzej
Girard, Pierre-Marie
Norton, Michael
Rouzioux, Christine
Taburet, Anne-Marie
Cohen-Codar, Isabelle
Van, Philippe Ngo
Chauvin, Jean-Pierre
[J]. AIDS, 2008, 22 (03) : 385 - 393
[5] Abacavir-lamivudine-zidovudine vs indinavir-lamivudine-zidovudine in antiretroviral-naive HIV-infected adults - A randomized equivalence trial
Staszewski, S
Keiser, P
Montaner, J
Raffi, F
Gathe, J
Brotas, V
Hicks, C
Hammer, SM
Cooper, D
Johnson, M
Tortell, S
Cutrell, A
Thorborn, D
Isaacs, R
Hetherington, S
Steel, H
Spreen, W
[J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2001, 285 (09): : 1155 - 1163
[6] An open randomized controlled trial of zidovudine plus lamivudine versus stavudine plus lamivudine
Foudraine, NA
de Jong, JJ
Weverling, GJ
van Benthem, BHB
Maas, J
Keet, IPM
Jurriaans, S
Roos, MTL
Vandermeulen, K
de Wolf, F
Lange, JMA
[J]. AIDS, 1998, 12 (12) : 1513 - 1519
[7] Amprenavir in combination with lamivudine and zidovudine versus lamivudine and zidovudine alone in HIV-1-infected antiretroviral-naive adults
Goodgame, JC
Pottage, JC
Jablonowski, H
Hardy, WD
Stein, A
Fischl, M
Morrow, P
Feinberg, J
Brothers, CH
Vafidis, I
Nacci, P
Yeo, J
Pedneault, L
[J]. ANTIVIRAL THERAPY, 2000, 5 (03) : 215 - 225
[8] Abacavir versus zidovudine combined with lamivudine and efavirenz, for the treatment of antiretroviral-naive HIV-infected adults
DeJesus, E
Herrera, G
Teofilo, E
Gerstoft, J
Buendia, CB
Brand, JD
Brothers, CH
Hernandez, J
Castillo, SA
Bonny, T
Lanier, ER
Scott, TR
[J]. CLINICAL INFECTIOUS DISEASES, 2004, 39 (07) : 1038 - 1046
[9] Body fat and other metabolic effects of atazanavir and efavirenz, each administered in combination with zidovudine plus lamivudine, in antiretroviral-naive HIV-infected patients
Jemsek, JG
Arathoon, E
Arlotti, M
Perez, C
Sosa, N
Pokrovskiy, V
Thiry, A
Soccodato, M
Noor, MA
Giordano, M
[J]. CLINICAL INFECTIOUS DISEASES, 2006, 42 (02) : 273 - 280
[10] 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)
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
[J]. AIDS, 2000, 14 (11) : 1591 - 1600

← 1 2 3 4 5 →