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About
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).
Enrollment
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Inclusion criteria
Patients meeting the following criteria will be eligible for participation in this study:
Signed informed consent prior to any study-related activities.
Documented HIV infection.
Male or female patients between 18 and 70 years of age inclusively.
Medication history, vital signs and physical exam adequately showing no signs of acute illness at screening, as per the assessment by the physician.
Patients must be willing to stop using any herbal or natural health products for 4 weeks prior to and during the study including:
Patients must be on an antiretroviral regimen with atazanavir/ ritonavir 300/100 mg daily as the only protease inhibitor plus any combination of nucleoside reverse transcriptase inhibitors, for at least four weeks.
VL<40 copies/mL on the most recent measurement, during treatment with atazanavir 300 mg daily and ritonavir 100 mg daily, which must be within 12 weeks of the study start date.
Reproductive Status: Definition of Women of Child-Bearing Potential (WOCBP). WOCBP comprises women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who are not post-menopausal (see definition below).
Exclusion criteria
Patients meeting one or more of the following criteria will be excluded from the study:
Female patients of childbearing potential who:
Patients with prior history of treatment failure on a PI based regimen, or with genotypic evidence of resistance associated mutations to protease inhibitors.
Use of any medication listed in Appendix I within 4 weeks prior to screening.
Use of any over-the-counter or prescription medications in the two weeks prior to Day 1 of the study that may interfere with absorption, distribution, metabolism or excretion of the study medications.
Inability to adhere to protocol.
Patients may be excluded from the study for other reasons, at the investigator's discretion.
Primary purpose
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12 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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