To compare the steady-state pharmacokinetics and short-term efficacy and safety of two dosing strategies of raltegravir and atazanavir in virologically suppressed HIV-infected adults receiving atazanavir-containing combination antiretroviral therapy.
Current HIV treatment guidelines recommend the construction of combination regimens comprising a minimum of three agents from at least two drug classes. There are problems with the current recommendations for although treatments are effective, their success is often limited by tolerability, adverse effects and the need to take many pills. Antiretroviral adherence remains vital and regimens should be simplified wherever possible to facilitate maximal adherence. The recent availability of the potent HIV integrase inhibitor, raltegravir, provides an opportunity to explore moves away from current regimen components. Evidence to support the use of novel regimens must be generated through adequately powered randomized clinical trials. However, before such trials can be undertaken, preliminary data to define the pharmacokinetics, safety and tolerability of these regimens are needed to minimize unnecessary risk for participants. This eight week study will investigate the steady-state pharmacokinetics, and short-term safety and efficacy of two dosing strategies (once and twice daily) of raltegravir plus atazanavir in treatment experienced HIV-infected adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
atazanavir 300 mg + raltegravir 400 mg twice daily for 4 weeks then atazanavir 300 mg + ritonavir 100 mg + raltegravir 800 mg once daily for 4 weeks
atazanavir 300 mg + ritonavir 100 mg + raltegravir 800 mg once daily for 4 weeks then atazanavir 300 mg + raltegravir 400 mg twice daily for 4 weeks
Holdsworth House Medical Practice
Sydney, New South Wales, Australia
St Vincent's Hospital
Sydney, New South Wales, Australia
comparison of the mean steady-state atazanavir trough plasma concentrations for once (C24) and twice (C12) daily dosing strategies
Time frame: 4 and 8 weeks
comparison of mean steady-state raltegravir trough plasma concentrations for once (C24) and twice (C12) daily dosing
Time frame: 4 and 8 weeks
comparison of steady-state pharmacokinetic profiles of once and twice-daily atazanavir
Time frame: 4 and 8 weeks
comparison of the steady-state pharmacokinetic profiles of once and twice-daily raltegravir
Time frame: 4 and 8 weeks
change from baseline in fasting lipid and glycaemic parameters
Time frame: weeks 4 and 8 and overall
change from baseline in CD4+ T-lymphocyte count
Time frame: weeks 4 and 8 and overall
change from baseline in HIV-RNA
Time frame: weeks 4 and 8 and overall
all adverse events attributable to study treatment
Time frame: week 8
all serious, grade 3 or 4 clinical adverse events, and any adverse event leading to premature cessation of study treatment
Time frame: week 8
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