TMC114IFD3001 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir(Rtv) in HIV1 Infected Adults, Adolescents and Children Aged 3 Years or Above and Coming From Previous Company Sponsored Studies With DRV

HIV-1 Infections Clinical Trial

Official title:

Continued Access to Darunavir/Ritonavir (DRV/Rtv) in HIV-1 Infected Adults, Adolescents and Children Aged 3 Years and Above

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03027297
• Other study ID #: CR017230
• Secondary ID: TMC114IFD3001
• Status: Active, not recruiting
• Phase: Phase 3
• First received: January 19, 2017
• Last updated: January 19, 2017
• Start date: August 2011
• Est. completion date: December 2018

Study information

• Verified date: January 2017
• Source: Janssen Sciences Ireland UC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this trial is to continue the provision of darunavir/ low-dose ritonavir (DRV/rtv) to adult and pediatric patients who previously received DRV/rtv in the clinical trials TMC114-C211, TMC114-C214, TMC114-TiDP31-C229 or in the pediatric trial TMC114-TiDP29-C232 who continue to benefit from the use of DRV/rtv, in countries where DRV is not commercially available for the subject, is not reimbursed, or cannot be accessed through another source (e.g., access program, governmental program).

Description:

This is a continued access trial for adult and pediatric patients who have completed treatment with darunavir in combination with low-dose ritonavir (DRV/rtv) in the clinical trials TMC114-C211, TMC114-C214, TMC114-TiDP31-C229 or in the pediatric trial TMC114-TiDP29-C232 who continue to benefit from the use of DRV/rtv, and who live in a country where DRV is not accessible. At the baseline visit, inclusion and exclusion criteria will be checked to confirm eligibility. Once the eligibility criteria are met, patients will continue treatment as follows: HIV-1-infected patients participating in the TMC114-C211 trial and some HIV-1 infected patients from the pediatric trial TMC114-TiDP29-C232 will continue on the selected DRV/rtv once daily dosing regimen as administered in the original trial, or (for pediatric patients) on an adjusted dose if necessary due to a change in body weight. Some HIV-infected patients from the pediatric trial TMC114-TiDP29-C232 will continue on the selected twice daily DRV/rtv dosing regimen as administered in the original trial, or (for pediatric patients) on an adjusted dose if necessary due to a change in body weight. HIV-1-infected patients having participated in the TMC114-C214 or TMC114-TiDP31-C229 trial will continue on the DRV/rtv 600/100 mg twice daily dosing regimen as administered in the original trial. Visits and assessment are performed according to local standard of care, but desirable every 3 months for pediatric patients and not less frequently than every 6 months for adult patients. The interval between 2 consecutive visits should not exceed 6 months for pediatric patients. Adverse events (AEs) considered at least possibly related to DRV/rtv, AEs leading to discontinuation or treatment interruption, serious AEs (SAEs), and pregnancies (or all AEs if applicable per local regulation) will be recorded at each visit. Patients will be instructed to report any AEs to the investigator, who will report SAEs within 24 hours to the Sponsor. In addition to the assessments in the flowchart, the following assessments are recommended to be performed locally every 3 months or according to local, generally accepted standards of care: efficacy assessments (immunology and plasma viral load) and laboratory safety assessments (hematology and biochemistry, including pancreatic amylase [if available] or lipase and lipid analyses). Treatment will be continued until one of the following criteria is met (whichever occurs first): virologic failure; treatment-limiting toxicity; loss to follow-up; withdrawal of consent/assent by the patient; withdrawal of consent by the parent(s)/legal representative(s); pregnancy; termination of the trial by the sponsor; DRV becomes commercially available for the patients, is reimbursed, or can be accessed through another source (eg, access program, government program) in the region the patient is living in. A post-treatment follow-up contact will be performed 4 weeks after the last dose of trial medication for patients with an ongoing adverse event. This is consistent with the primary objective of the study to provide continued access to DRV/rtv for adult patients who previously received DR/rtv in the clinical trials sponsored by Tibotec Pharmaceuticals. This study is not set up to address any specific hypothesis. Depending on the previous trial the patients were in, they will continue to take either : DRV/rtv 800/100 mg once a day as 2 tablets of 400 mg DRV and 100 mg ritonavir; or DRV/rtv 600/100 mg twice a day as 1 tablet of 600 mg DRV and 100 mg ritonavir twice a day; DRV/rtv 375/100 mg twice a day as 1 tablet of 375 mg DRV and 100 mg ritonavir; DRV/rtv selected dose twice daily , or on an adjusted dose if necessary due to a change in body weight.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 133
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

• Patients treated with DRV/rtv who have successfully completed the TMC114-C211, TMC114-C214, TMC114-TiDP31-C229 trial or the pediatric trial TMC114-TiDP29-C232 and in the opinion of the investigator continue to receive benefit from using DRV/rtv

• DRV is not commercially available for the patients, is not reimbursed, or cannot be accessed through another source (eg, access program, government program) in the region the patient is living in.

• Patients (where appropriate, depending on age) and the parent(s) or legal representative(s) have signed the Informed Consent/Assent Form voluntarily. Children will be informed about the program and asked to give assent (where appropriate, depending on age).

Exclusion Criteria:

• Any condition (including but not limited to alcohol and drug use) which, in the opinion of the investigator, could compromise the patient's safety or adherence to treatment with DRV/rtv

• Any active, clinically significant disease (such as pancreas or cardiac problems) or findings which could compromise the patient's safety during treatment with DRV/rtv

• Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (DRV) or ritonavir

• Pregnant or breastfeeding female patients.

Related Conditions & MeSH terms

• HIV-1 Infections

Intervention

Drug:
• Darunavir
600 mg tablet, intake of 1 tablet twice a day in combination with ritonavir
• Ritonavir
100 mg capsule, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
• Darunavir
400 mg tablet, intake of 2 tablets once daily in combination with ritonavir
• Ritonavir
100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
• Darunavir
375 mg tablet (made up of 2 x 150mg +1 x 75mg tablets), intake of 3 tablets twice a day in combination with Ritonavir
• Darunavir
Darunavir oral suspension (dose dependant on weight) in combination with Ritonavir
• Ritonavir
Ritonavir oral solution as 80 mg/mL (dose dependant on weight) in combination with Darunavir twice daily
• Ritonavir
Ritonavir powder for oral suspension prepared as 100 mg/10 mL (dose dependant on weight) in combination with Darunavir

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Sciences Ireland UC

Countries where clinical trial is conducted

Costa Rica,  Guatemala,  Malaysia,  Panama,  South Africa,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All serious adverse events, adverse events leading to discontinuation, and adverse events at least possibly related to the DRV treatment, as measures of the safety and tolerability of DRV/rtv in combination with other ARVs		Approximately up to 7 years