Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Colorado, Denver
With
National Institute of Allergy and Infectious Diseases (NIAID)
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Age 18 to 55 years
Negative HIV screening antibody test
CYP3A5 expressor status, race, and sex fit an enrollment opening.
You may not be 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.
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.
Clareo Health | Genetics and HIV-1 Protease Inhibitors
