A Study to Assess the Safety and Effectiveness of Darunavir for Treating Human Immunodeficiency Virus-Type I (HIV-1) Infection in Filipino Patients

Janssen (J&J Innovative Medicine)

Status: Withdrawn

Conditions: Human Immunodeficiency Virus-Type 1

Treatments: Drug: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01726348

PRE-PHL-MA1 (Other Identifier)

TMC-C-07-PH-007 (Other Identifier)

CR014686

TMC114HIV4013 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This is an open-label (all people know the identity of the intervention), multi-center (study conducted at multiple sites), uncontrolled (all the patients receiving darunavir) clinical and observational study (study in which the investigators/physicians observe the patients and measure their outcomes) to evaluate the safety and effectiveness of darunavir for the treatment human immunodeficiency virus-type 1 (HIV-1) infection among adult Filipino patients. The study will enroll 10 percentage of patient who would use the product, as a requirement of the Philippine Food and Drug Administration (FDA). Patients will be monitored from baseline and every 4 weeks thereafter for a period of 24 weeks. Safety evaluations for adverse events, clinical laboratory tests, physical examination, concomitant medications, and co-morbid conditions will be monitored throughout the study. The duration of treatment will be for 24 weeks and the total study will be conducted for 3 years.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

0 participants in 1 patient group

Darunavir

Description:

Patients will be taking darunavir as per the dosing regimen given on product insert approved in Philippines.

Treatment:

Drug: No intervention