Human Immunodeficiency Virus-Type 1
Conditions
Keywords
Human Immunodeficiency Virus-Type 1, HIV-1, TMC114, Darunavir, Ritonavir, Filipino
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.
Interventions
DRUGNo 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.
Sponsors
Janssen Pharmaceutica
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with incidence of adverse events | Up to 24 weeks |
| Number of patients with incidence of discontinuation of study medication due to adverse events | Up to 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean decrease of viral load at the end of treatment from baseline | Baseline, Week 12, and Week 24 | — |
| Number of patients with viral load of 50 copies per ml at the end of treatment | Baseline, Week 12, and Week 24 | — |
| Number of patients with lack of effect | Up to 24 weeks | Any failure of expected pharmacologic action of the study medication |
Outcome results
None listed