10th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV


6-8 November 2008, London, UK

THE IMPACT OF RALTEGRAVIR AND LOPINAVIR/RITONAVIR ON PERIPHERAL GLUCOSE DISPOSAL IN HIV-NEGATIVE SUBJECTS

Antiviral Therapy 2008; 13(Suppl. 4):A18 (abstract no. O-25)

P Randell, A Jackson, K Dennis and G Moyle
Chelsea & Westminster Hospital, London, UK

OBJECTIVES: This study investigated the impact of raltegravir and lopinavir/ritonavir on the peripheral glucose disposal rate (M), assessed using the hyperinsulinaemic euglycaemic clamp, in HIV-negative male subjects.

METHODS: An open-label, two phase crossover study design was used. Important exclusion criteria were body mass index >28 kg/m2, waist-to-hip ratio >0.97 and any medication or disease process likely to cause marked disturbances on lipid and glucose homeostasis. Fasting glucose, cholesterol and triglycerides all had to be within normal limits. Subjects were randomized 1:1 to receive 2 weeks of lopinavir/ ritonavir 400/100 mg twice daily followed by a 2-week washout period then 2 weeks of raltegravir 400 mg twice daily or raltegravir initially followed by lopinavir/ritonavir. A clamp was performed prior to and following each 2-week phase of study medication.

RESULTS: In total, 16 subjects completed all four clamps. Data from the lopinavir/ritonavir phase was not included in the analysis for one subject because of poor compliance with dosing during these 2 weeks. The mean (sem) percentage change from baseline was -16.10 (3.84) after 2 weeks of lopinavir/ritonavir and -0.43 (4.83) after 2 weeks of raltegravir (See Table 1).

CONCLUSIONS: In HIV-negative male subjects, 2 weeks of raltegravir was not associated with a significant impact on the M assessed during the euglycaemic clamp. In contrast, 2 weeks of lopinavir/ritonavir resulted in a significant reduction in the M, which is consistent with previously published findings.

Table 1. (Abstract O-25)
Study medication Mean baseline M, mg/kg/min (sem) Mean 2-week change in M, mg/kg/min (95% CI)
Lopinavir/ritonavir (n=15) 7.97 (0.33) -1.30* (-1.94–-0.66)
Raltegravir (n=16) 8.30 (0.31) -0.13 (-0.86–0.60)
*P=0.001 for the difference from baseline to week 2 (paired t-test). CI, confidence interval; M, peripheral glucose disposal rate.

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2008-11-06
O-25

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