Genetics and HIV-1 Protease Inhibitors
Completed · Phase 4
Conditions studied: HIV
In brief
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.
Key facts
- Study ID
- NCT01388543
- Run by
- University of Colorado, Denver
- People needed
- 31
- Starts
- 2006-09-01
- Expected to finish
- 2008-06-01
- Last updated by the study team
- 2019-11-19
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age 18 to 55 years
- Negative HIV screening antibody test
- CYP3A5 expressor status, race, and sex fit an enrollment opening.
You may not qualify if…
- 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.
Where it is running
- University of Colorado Denver and Health Sciences Center — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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