Sixth International Congress

Drug Therapy in HIV Infection


17-21 November, 2002
Glasgow, UK

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Interim analysis of a phase IV, randomised, open-label, multicentre trial to evaluate safety and efficacy of lopinavir/ritonavir (400/100 mg bid) vs. saquinavir/ritonavir (1000/100 mg bid) in adult HIV-1 infection. The MaxCmin2 trial

Ulrik Bak Dragsted1, J D Lundgren1 2, J Gerstoft, M Youle, A Duran, D TJayaweera, A Rieger,J NBruun, A Castagna, SWalmsley, Z Fox, A Hill2
Int Cong Drug Therapy HIV 2002 Nov 17-21;6:Abstract No. PL14.5

[ABSTRACT:] Few comparative data exists on the efficacy and safety of ritonavir(r)-boosted protease inhibitor regimens in the average HIV-1 infected population seen in out-patients’ clinics. The primary objective of the trial is to compare the rate of virological failure at 48 weeks for the lopinavir/r arm (400/100 mg bid) relative to the saquinavir/r arm (1000/100 mg bid). Further, to compare the proportion of patients with virological failure, HIV-1 RNA < 400 c/ml, discontinuation of the assigned treatment (tx) at 24 and 48 weeks, and safety. The trial is randomised (1:1), phase IV, open-label, and multi-centre including a heterogeneous adult HIV-1 infected population. Concomitant use of ≥ 2 NRTI/NNRTI was decided prior to randomisation by the treating physician. From June to December 2001, 339 patients were enrolled, of whom 317 initiated the assigned tx (analysis population). At Baseline no differences between the study arms were observed in demographic, clinical and laboratory variables (see table). Thirty-four % of patients were ART naïve at enrolment. Through Week 24, 17% had discontinued the assigned tx primarily due to an adverse event(s). The trial has recruited a diverse patient population that is well balanced for demographic, clinical, and laboratory variables. The primary reason for discontinuation of the assigned tx is development of adverse events. The interim analysis on complete Week 24 efficacy and toxicity data – stratified for randomisation – will be presented.

Baseline parameter LPV/r arm SAQ/r arm Total
n = 160 n = 157 n = 317
Gender (% male) 77 82 80
Age (median, IQR) 40 (35-46) 40 (35-50) 40 (35-48)
HIV exposure group (%)
    Homosexual/bisexual 45 47 46
    Heterosexual 39 35 37
    IVDU 8 8 8
    Other & unknown 9 10 9
PI-naïve (%) 49 50 49
PI-experienced with
    viral load ≥ 400 c/ml (%) 32 32 32
    viral load < 400 c/ml (%) 19 18 19
CD4+ (106/l; median, IQR) 238 (95-420) 238 (73-383) 238 (92-413)
CD4+ nadir (106/l; median, IQR) 94 (30-196) 100 (30-225) 98 (30-210)
CDC, clinical cat. C (%) 30 32 31
HIV-1 RNA (median c/ml log10, IQR) 4.6 (3.4-5.3) 4.5 (3.5-5.1) 4.6 (3.4-5.3)
HIV-RNA < 400 c/ml (%) 22 20 21

Presenting author: Ulrik Bak Dragsted

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1 Copenhagen HIV Programme (CHIP), Hvidovre University Hospital, Denmark

2 The MaxCmin2 trial group

2002-11-17
PL14-5

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