Human immunodeficiency virus [HIV] disease
Conditions
Interventions
58 subjects
Darunavir, 800mg (2 tablets of 400 mg), oral, once a day, continuous use associated to Ritonavir, 100 mg, oral, once a day, continuous use, during study.
Drug
Sponsors
Hospital Geral de Nova Iguaçu
Janssen Research and Development*
Inc Research Br Serviços de Pesquisa Clínica LTDA
Eligibility
Age
3 Years to 17 Years
Inclusion criteria
Inclusion criteria: Male or female subjects, aged 3 years and above.Subject has completed the TMC114-C212, TMC114-TiDP29-C228 or TMC114-TiDP29- C230 trial, and in the opinion of the investigator continues to receive benefit from using Darunavir. Darunavir is not commercially available for the pediatric subject, is not reimbursed, or cannot be accessed through another source in the region the subject is living in. Subject and the parent(s) or legal representative(s)have signed the Informed Consent Form voluntarily.
Exclusion criteria
Exclusion criteria: Any condition which, in the opinion of the investigator, could compromise subjects’ safety or adherence to treatment with Darunavir. Any active clinically significant disease or findings of medical history, laboratory or physical examination that, in the opinion of the investigator, would compromise subjects’ safety during treatment with Darunavir. Previously demonstrated clinically significant allergy or hypersensitivity to Darunavir or to Ritonavir. Pregnant or breastfeeding female subjects. Female subject of childbearing potential without use of effective birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the safety and tolerability of Darunavir/Ritonavir in combination with other antiretrovirals across indicative of mortality, serious adverse events; adverse events leading to discontinuation; adverse events considered related to Darunavir treatment during the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected | — |
Countries
Argentina, Brazil, France, India, Ireland, Italy, Kenya, South Africa, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactLivia Gomes
Inc Research Br Serviços de Pesquisa Clínica LTDA
Outcome results
None listed