Clinical trial NCT01726348: A Study to Assess the Safety and Effectiveness of Darunavir for Treating Human Immunodeficiency Virus-Type I (HIV-1) Infection in Filipino Patients
Official 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Human Immunodeficiency Virus-Type 1
Keywords: Human Immunodeficiency Virus-Type 1
HIV-1
TMC114
Darunavir
Ritonavir
Filipino
Lead sponsor: Janssen Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2012-11-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adult Filipino patients who are diagnosed with human immunodeficiency virus-type 1 (HIV-1), and who are eligible for darunavir (in combination with ritonavir) treatment.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with incidence of adverse events
timeFrame: Up to 24 weeks
measure: Number of patients with incidence of discontinuation of study medication due to adverse events
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Mean decrease of viral load at the end of treatment from baseline
timeFrame: Baseline, Week 12, and Week 24
measure: Number of patients with viral load of 50 copies per ml at the end of treatment
timeFrame: Baseline, Week 12, and Week 24
measure: Number of patients with lack of effect
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Pharmaceutica
name: Janssen Pharmaceutica Clinical Trial
role: STUDY_DIRECTOR
References: