14th International AIDS Conference


Barcelona, Spain — July 7-12, 2002
[TITLE:] Safety and efficacy evaluation of a phase IV randomised, open-label, multicentre trial of indinavir/ritonavir (800/100 mg bid) vs. saquinavir/ritonavir (1000/100 mg bid) in adult HIV-1 infection: The MaxCmin1 trial

[AUTHOR(S):] P Cahn, U B Dragsted, C Pedersen, B Peters, A Duran, N Obel, J M Gatell, C Leen, J V Lunzen, A Stoehr, J Lederman, J D Lundgren1

Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. WeOrB1265

BACKGROUND: This trial is the first head-to-head comparison of ritonavir(r)-boosted PI treatments (tx). The objectives of the trial were to compare virological outcome between the study arms including the proportion of patients with HIV-RNA < 400 c/ml at 48 weeks, to compare the proportion of patients experiencing (serious) adverse events ((S)AEs), and that discontinued the randomised tx prematurely.

METHODS: Open-label, randomised (1:1), multi-centre, phase IV trial evaluating the safety and efficacy of indinavir/r (IDV/r) vs. saquinavir (SAQ/r) in HIV-1 infected patients (age >18) at 48 weeks of tx. Concomitant use of > 2 NRTI/NNRTI was decided prior to randomisation by the treating physician.

RESULTS: The randomised tx was initiated in 306 of 317 randomised patients. No differences were observed at baseline between the study arms in demographic, clinical or laboratory variables nor in the use of any antiretroviral drug prior to inclusion or at baseline. Through December 2001 (equal to 90 % of follow-up), 98 (32 %) patients had discontinued the randomised tx - 56/158 (35 %) in the IND/r arm vs. 42/148 (28 %) in the SAQ/r arm - primarily due to G-I toxicity: 16 (10 %) vs. 13 (9 %), respectively. Only 7 (2 %) were lost to follow-up. HIV-1 RNA was < 400 c/ml in 87 % of patients (123/141) at Week 48. A total of 133 AEs grade 3 or 4 were reported in 50 (32 %) patients in the IND/r arm vs. 29 (20 %) in the SAQ/r arm (see table), of which 7 vs. 4 patients had abnormal liver function test. Further, 68 SAEs were reported in 28 (18 %) patients in the IND/r arm vs. 21 (14 %) in the SAQ/r arm. Complete Week 48 data will be available in May 2002.

Adverse Event
(grade 3 & 4)
IDV/r
(n = 83)
SAQ/r
(n = 50)
Total
(n = 133)
Serious Adverse Event
(hosp. adm., life threat., fatal)
IDV/r
(n = 36)
SAQ/r
(n = 32)
Total
(n = 68)
Cardio-pulm.
7
1
8
 Cardio-pulm.
6
7
13
Renal
10
0
10
 Renal
5
0
5
Other G-I
18
16
34
 Other G-I
8
9
17
Nervous system
7
4
11
 Nervous system
6
6
12
Skin
3
2
5
 Skin
1
1
2
Fever & fatigue
3
3
6
 Fever & fatigue
3
2
5
Laboratory
15
16
31 *
 Laboratory
1
2
3
Other
20
8
28
 Other
6
5
11
* LFT (11)
hyperlipidemia (7)
haematology (6)
hyperglycedemia (3)

CONCLUSIONS: The two regimens result in virological control in most patients and are reasonably well tolerated. More patients in the IND/r than in the SAQ/r arm experienced (S)AEs. The final analysis of Week 48 toxicity and efficacy data – stratified for randomisation - will be presented.

Presenting author: P Cahn

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1Fundación HUESPED, CHIP, Dept. of Infectious Diseases 144, Hvidovre University Hospital

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WeOrB1265

Copyright © 2002 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.