Microboosting of Atazanavir 300 mg With 50 mg Versus 100mg Ritonavir Daily in HIV-infected Patients: a Pharmacokinetic Study
This is an open-label, single group study to determine the pharmacokinetic profile of atazanavir 300 mg daily boosted with ritonavir 100mg daily in HIV-infected patients over a period of 9 days.
Ritonavir and atazanavir are protease inhibitors used to treat HIV. However, ritonavir, when used at low doses (up to 100mg) does not have HIV activity, but will enhance (boost) the blood concentrations of other drugs like atazanavir.
Recently, a study showed that taking 50mg of ritonavir administered in an oral solution led to similar blood concentrations of atazanavir than when given with 100mg of ritonavir. Potential benefits associated with a lower dose of ritonavir may include a reduction of side effects such as upset stomach and an improvement in cholesterol level. This study will look at the amount of atazanavir into your blood when given with ritonavir in a tablet formulation at 50mg or 100mg with standard atazanavir dose (300mg).
|HIV Infection||Drug: atazanavir 300mg boosted with ritonavir 50 mg||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Microboosting of Atazanavir 300 mg With 50 mg Versus 100 mg Ritonavir Daily in HIV-infected Patients: a Pharmacokinetic Study|
- Pharmacokinetics [ Time Frame: 9 days ]main pharmacokinetic parameters of atazanavir: AUC0-24h, Cmax and Cmin.
- adverse events [ Time Frame: 9 days ]the main pharmacokinetic parameters of ritonavir: AUC0-24h, Cmax and Cmin, , adverse events and preference, as reported by patients during the study period.
|Study Start Date:||January 2014|
|Study Completion Date:||September 2015|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: atazanavir 300mg boosted with ritonavir 100mg
Two period drug interaction. Period one: atazanavir 300mg boosted with ritonavir 100 mg once daily as part of current treatment standard of care.
Period two: atazanavir 300 mg boosted with ritonavir 50 mg once daily for study days 2-8 inclusive
Drug: atazanavir 300mg boosted with ritonavir 50 mg
atazanavir 300 mg with ritonavir 100 mg once a day at 8:00 am for study day 1 and 9.
atazanavir 300 mg with ritonavir 50 mg once a day at 8:00 am for 7 consecutive days (study days 2-8)
Please refer to this study by its ClinicalTrials.gov identifier: NCT02034838
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1H 8L6|
|Principal Investigator:||William Cameron, MD, FRCPC||The Ottawa Hospital|