The purpose of this study is to assess the safety and effectiveness of darunavir for the
treatment human immunodeficiency virus-type I (HIV-1) infection among Filipino adults.
Drug: No intervention
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Locations near you
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Full eligibility criteria for NCT01726348
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Patients who are diagnosed with human immunodeficiency virus-type 1 (HIV-1), and who are eligible for darunavir (in combination with ritonavir) treatment. These may be either: treatment-naive adult patients and treatment-experienced adult patients with no darunavir resistance associated substitutions; or treatment-experienced adult patients with at least one darunavir resistance associated substitution
Known hypersensitivity to darunavir/ritonavir or to any of the components of the two agent preparations
Pregnant or breastfeeding females
Agrees to protocol-defined use of effective contraception
Patients taking medication that are highly dependent on Cytochrome P450 3A4 for clearance and for which initial concentrations are associated with serious and/or life threatening events
Patients with severe hepatic impairment
History of allergy to sulfa containing drugs or molecules
Patients currently receiving alfuzosin, dihydroergotamine, ergonovine, ergotamine, methylergonavine, cisapride, pimozide, midazolam, triazolam, St. John's Wort
(Hypericum perforatum), lovastatin, simvastatin, rifampin and sildenafil
All locations for NCT01726348
View full eligibility
Tris trial is registered with FDA with number: NCT01726348. The sponsor of the trial is Janssen Pharmaceutica and it is looking for 0 volunteers for the current phase.
Official trial title: A Post-Marketing Surveillance Study on the Safety and Effectiveness of Darunavir on Filipino Patients With Human Immunodeficiency Virus-Type I (HIV-1) Infection
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