Eligibility Details:
Inclusion Criteria:
- Men and women who are between the ages of 18 and 55 years
Exclusion Criteria include the following:
- For all female participants, a urine pregnancy test will be done on each testing day.
Only those with a negative pregnancy test will be allowed to participate in taste
testing.
- Smokers will be excluded since it alters flavor perception.
- Potential subjects will be excluded if they are on drugs with potential serious
adverse effects that are mediated through CYP450 3A4 since ritonavir is a potent
inhibitor of CYP450 3A4 and could lead to elevated levels of the prohibited drugs if
swallowed. The prohibited drugs include the following:
- Alfuzosin (Uroxatral; alpha-1-adrenoreceptor antagonist)
- Astemizole (Hismanal; antihistamine)
- Bepridil (Vascor; calcium channel blocker)
- Cerivastatin (Baycol; statin)
- Cisapride (Propulsid; GI motility agent)
- Dronedarone (multaq; anti-arrhythmic)
- Ergotamine (Cafergot, Ergot derivatives)
- Flecainide (Tabocor; anti-arrhythmic)
- Lovastatin (Altoprev; HMG-CoA Reductase Inhibitor)
- Lurasidone (Latuda; antipsychotic)
- Midazolam (Versed; sedative/hypnotic)
- Pimozide (Orap; antipsychotic)
- Ranolazine (Ranexa; anti-anginal)
- Simvastatin (Zocor; statin)
- Terfenadine (Seldane; antihistamine)
- Tinidazole (Tindamax; anti-parasitic)
- Trazodone (Desyrel; antidepressant/sedative)
- Triazolam (Halcion; sedative)
- Warfarin (Coumadin; blood thinner)
- Potential subjects will be excluded if they have had current (within the last 24
hours) use of sildenafil (Viagra), tadalafil (Cialis), and verdenafil (Levitra) are
also exclusion criteria. These drugs can be used as needed for erectile dysfunction.
They are also used as a daily treatment for pulmonary arterial hypertension. With
CYP450 3A4 blockade and current use, hypotension, syncope, and prolonged erection are
possible.
- Potential subjects will be excluded if they have known allergies or hypersensitivity
reactions to lopinavir, ritonavir, clindamycin, prednisone, dexamethasone, ibuprofen,
6-mercaptopurine, propylthiouracil, or any of the excipients in the liquid
formulations to be tested.