Continued access to darunavir/ritonavir (DRV/rtv) in HIV-1 infected children and adolescents aged 3 years and above

• Conditions: HIV-1; MedDRA version: 12.1Level: LLTClassification code 10020161Term: HIV infection

• Registration Number: EUCTR2009-017013-29-FR
• Lead Sponsor: Tibotec Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-14
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1. Male or female subjects, aged 3 years and above.
2. 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 DRV.
3. DRV is not commercially available for the pediatric subject, is not reimbursed, or cannot be accessed through another source (e.g., access program, government program) in the region the subject is living in.
4. Subject (where appropriate, depending on age) and the parent(s) or legal representative(s) have signed the Informed Consent Form voluntarily. Children will be informed about the program and asked to give assent (where appropriate, depending on age).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any condition (including but not limited to alcohol and drug use) which, in the opinion of the investigator, could compromise subjects’ safety or adherence to treatment with DRV.
2. Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or findings of medical history, laboratory or physical examination that, in the opinion of the investigator, would compromise subjects’ safety during treatment with DRV.
3. Previously demonstrated clinically significant allergy or hypersensitivity to DRV or to ritonavir, or any of the excipients of DRV or ritonavir.
4. Pregnant or breastfeeding female subjects.
5. 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.
Note: Estrogen hormonal based contraception may not be reliable when taking DRV/rtv. Therefore, to be eligible for this trial female subjects of childbearing potential should either:
a. Use a double-barrier method to prevent pregnancy (i.e., use a male condom with either diaphragm or cervical cap)*; or b. Use non-estrogen hormonal based contraceptives in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom); or c. Use an intra-uterine device (IUD) in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom); or d. Be non-heterosexually active, practice heterosexual abstinence, or have a vasectomized partner (confirmed sterile).
* A male and female condom should not be used together due to the risk of breakage or damage caused by latex friction.
6. Heterosexually active male subject not using 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: Interventional clinical trial of medicinal product
• Study Design: Not specified