An observational study in Human Immunodeficiency Virus-Type 1, sponsored by Janssen Pharmaceutica. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-02.
Sponsored by Janssen Pharmaceutica · Observational
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.
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.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →Janssen Pharmaceutica is the lead sponsor of 15 studies on the registry; none are open to participants now.
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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.
Exclusion Criteria:
Patients will be taking darunavir as per the dosing regimen given on product insert approved in Philippines.
Drug: No intervention
This is an observational study. Darunavir will be administered as per the recommended doses and will be given orally every 4 weeks for a period of 24 weeks. For treatment-naive and treatment-experienced adult patients with no darunavir resistance associated substitutions: Darunavir 800 mg will be administered with ritonavir 100 mg once daily with food. For treatment-experienced adult patients with at least one darunavir resistance associated substitution: Darunavir 600 mg will be administered with ritonavir 200 mg twice daily with food.
Number of patients with incidence of adverse events
Time frame: Up to 24 weeks
Number of patients with incidence of discontinuation of study medication due to adverse events
Time frame: Up to 24 weeks
Mean decrease of viral load at the end of treatment from baseline
Time frame: Baseline, Week 12, and Week 24
Number of patients with viral load of 50 copies per ml at the end of treatment
Time frame: Baseline, Week 12, and Week 24
Number of patients with lack of effect
Any failure of expected pharmacologic action of the study medication
Time frame: Up to 24 weeks
No study locations are listed for this record.
This study is withdrawn, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
Janssen Pharmaceutica