NCT01388543CompletedPhase 4
Genetic-determinants of Protease Inhibitor Pharmacology
University of Colorado, Denver1 site in 1 country31 target enrollmentStarted: September 2006Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Day 7 Atazanavir Oral Clearance
Study Overview
Brief Summary
This study evaluated the blood levels of atazanavir according to a genetic makeup for CYP3A5 (cytochrome P450 3A5, an enzyme that metabolizes atazanavir). The hypothesis was that people with a slow-metabolizing genotype would have higher blood levels of atazanavir compared to people with the normal metabolizing genotype.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 18 to 55 years
- •Negative HIV screening antibody test
- •CYP3A5 expressor status, race, and sex fit an enrollment opening.
Exclusion Criteria
- •Pregnant or breast-feeding
- •Medical history of
- •hepatitis B or C,
- •autoimmune disease,
- •active malignancy,
- •kidney disease including nephrolithiasis
- •Organ dysfunction manifested by
- •liver transaminases or
- •serum creatinine >1.25 times the upper limit of normal, or
- •any comprehensive metabolic test (except asymptomatic unconjugated hyperbilirubinemia), blood count, or lipid value > Grade I according to Division of AIDS (DAIDS) adverse drug event grading system (appendix).
- •Medical history of arrhythmias (including atrial fibrillation, atrioventricular block, and/or pacemaker)
- •Any QT interval abnormalities or other congenital arrhythmia syndromes on ECG or
- •Any ECG abnormality that in the opinion of the investigators would preclude entry into the study.
- •Medical history of any serious heart condition including:
- •congestive heart failure,
- •myopathies,
- •coronary artery disease, or
- •unexplained syncope.
- •Medical history of bleeding disorders (i.e., hemophilia)
- •Hyperlipidemia
- •Any prescription, herbal, recreational, or over-the-counter medication contraindicated with ritonavir or atazanavir including:
- •substrates/inhibitors/inducers of CYP3A/P-gp,
- •cardio-active medication, or
- •medications that alter the acid in the stomach. The study investigators will review each concurrent medication on a case-by-case basis.
- •Inability to refrain from grapefruit or grapefruit juice during the study.
- •Investigational drugs within the last 30 days.
- •Active alcohol / recreational drug abuse,
- •Inability to give informed consent.
- •A body mass index below 18.5 or above 34.
Arms & Interventions
CYP3A5 Expressors
Active Comparator
A pre-screening genetic test determines CYP3A5 expressor status
Intervention: Atazanavir (Drug)
CYP3A5 Non-expressors
Active Comparator
A pre-screening genetic test determines CYP3A5 non-expressor status
Intervention: Atazanavir (Drug)
Outcomes
Primary Outcomes
Day 7 Atazanavir Oral Clearance
Time Frame: Day 7
Measure atazanavir oral clearance in genetically-determined CYP3A5 expressors versus CYP3A5 non-expressors
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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