Continued treatment with darunavir/ritonavir in children and adolescents aged 3 years and above with HIV-1

Not Applicable

Active, not recruiting

• Conditions: Human immunodeficiency virus [HIV] disease; Unspecified human immunodeficiency virus [HIV] disease; B20-B24

• Registration Number: RBR-2wjncp
• Lead Sponsor: Hospital Geral de Nova Iguaçu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-28
• Last Update Posted: 2023-05-29

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified