Understanding Nuclear Magnetic Resonance Spectroscopy Principles
Revealing the intricacies of NMR spectroscopy, explore the regions in the 1H NMR spectrum, understand local-field contributions, integrated intensity of peaks, and spin-spin splitting rules. Delve into the N+1 rule, coupling constants, and learn the significance of non-equivalent nuclei interactions. Unravel the complex relationship between protons for a deeper insight into molecular structures.
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Switch to LPV/r monotherapy Pilot LPV/r M03-613 LPV/r Mono KalMo OK OK04 KALESOLO MOST HIV-NAT 077
KALESOLO Study: Switch to LPV/r monotherapy Design Randomisation* 1 : 1 Open-label W48 N = 99 Continuation current triple antiretroviral therapy (CART) HIV+ 18 years On stable cART > 3 months No history of prior virologic failure on PI HIV-1 RNA < 50 c/mL > 6 months N = 87 LPV/r 400/100 mg bid * Randomisation was stratified by centre, and ongoing treatment (LPV/r, PI other than LPV/r, NNRTI) Objective Non inferiority of the monotherapy group in the proportion of patients with HIV-1 RNA < 50 c/mL at W48 without modification of treatment (per-protocol analysis) ; lower limit of two-sided 90% CI for the difference = - 12%, 80% power Patients lost to follow-up or with no HIV-1 RNA value at W48 were considered as failures (missing = failure) KALESOLO Meynard JL, JAC 2010;65:2436-44
KALESOLO Study: Switch to LPV/r monotherapy Baseline characteristics and patient disposition Continuation of cART N = 99 43 24% 28% 525 96% 15.7 LPV/r monotherapy N = 87 44 28% 25% 494 94% 28.6 Median age, years Female CDC stage C CD4 cell count, median/mm3 HIV-RNA < 50 c/mL ARV at inclusion 3TC/FTC ZDV TDF ABC ddI 78% 38% 33% 21% 15% 80% 41% 25% 21% 16% 25% 29% NNRTI 33% ; 41% 9 32% ; 39% 10 (6 re-intensified) PI: LPV/r ; other PI Discontinuation by W48, n Meynard JL, JAC 2010;65:2436-44 KALESOLO
KALESOLO Study: Switch to LPV/r monotherapy Virologic outcome at W48 HIV-1 RNA < 50 c/mL HIV-1 RNA < 50 c/mL with re-intensification allowed Therapeutic failure % 91 88 100 88 cART N = 12 LPV/mono N = 14 84 75 HIV-1 RNA > 50 c/mL 0 5 HIV-1 RNA measure missing 50 5 0 Change of ARV For virologic failure For adverse event 7 0 3 10 8 1 25 N= 99 87 99 87 0 95% CI 95% CI for the difference = - 12.4 ; 4.5 for the difference = - 4.5 ; 10.4 Continue cART LPV/r mono Non inferiority of LPV/r monotherapy not demonstrated Meynard JL, JAC 2010;65:2436-44 KALESOLO
KALESOLO Study: Switch to LPV/r monotherapy Other outcomes Multivariate analysis: treatment failure was not associated with adherence to therapy but was associated with older age at baseline Of samples with HIV-1 RNA > 50 c/mL, 20 genotypes from 14 patients (all in the LPV/r monotherapy group) could be analysed: 1 patient developed major PI resistance mutation, no patient developed mutations conferring resistance to LPV/r For lipids, fasting total cholesterol changes were significantly higher in the LPV/r monotherapy group (+ 0.42 mmol/L vs + 0.08 mmol/L ; p = 0.04) None of the 12 serious adverse events were drug-related Grade 3 to 4 laboratory abnormalities occurred in 3 patients in each group Diarrhoea was more frequent in the LPV/r monotherapy group (N = 34 vs N = 13 ; p < 0.001) Meynard JL, JAC 2010;65:2436-44 KALESOLO
KALESOLO Study: Switch to LPV/r monotherapy Conclusions In patients with virologic suppression, by per-protocol analysis, LPV/r monotherapy did not achieve non inferiority versus continuation of current antiretroviral regimen for maintaining HIV-1 RNA < 50 c/mL The incidence of virologic failure was low and successfully managed by treatment reintensification Meynard JL, JAC 2010;65:2436-44 KALESOLO
