Genetics and HIV-1 Protease Inhibitors

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.