Overview

This trial is active, not recruiting.

Condition hiv-1 infections
Treatments darunavir, ritonavir
Phase phase 3
Sponsor Janssen R&D Ireland
Start date August 2011
End date December 2017
Trial size 133 participants
Trial identifier NCT01281813, CR017230, TMC114IFD3001

Summary

The primary objective of this trial is to continue the provision of DRV/rtv to adult patients who have completed treatment with DRV/rtv in the clinical trials TMC114-C211, TMC114-C214, or TMC114-TiDP31-C229, sponsored by Tibotec Pharmaceuticals, who continue to benefit from the use of DRV/rtv, and who live in a country where DRV is not commercially available, is not reimbursed, or cannot be accessed through another source (eg, access program, government program).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Darunavir 400 mg tablet intake of 2 tablets once daily in combination with ritonavir
darunavir
400 mg tablet, intake of 2 tablets once daily in combination with ritonavir
(Experimental)
Darunavir 600 mg tablet intake of 1 tablet twice a day in combination with ritonavir
darunavir
600 mg tablet, intake of 1 tablet twice a day in combination with ritonavir
(Experimental)
ritonavir 100 mg capsule to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
ritonavir
100 mg capsule, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
(Experimental)
ritonavir 100 mg tablet to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
ritonavir
100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule

Primary Outcomes

Measure
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
time frame: Upto 4 years (ie Qtr 1 2015)

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: - Patients treated with DRV/rtv who have successfully completed the TMC114-C211, TMC114-C214, or TMC114-TiDP31-C229 trial 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. 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.

Additional Information

Official title Continued Access to Darunavir/Ritonavir (DRV/Rtv) in HIV-1-Infected Adults (Roll Over Patients From C211, C214 & C229)
Description This is a continued access trial for adults who have completed treatment with darunavir / ritonavir (DRV/rtv) in the clinical trials TMC114-C211, TMC114-C214, or TMC114-TiDP31-C229, sponsored by Tibotec Pharmaceuticals, 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 will continue on the DRV/rtv 800/100 mg once daily dosing regimen and emtricitabine / tenofovir (TDF/FTC) as administered in the original trial. HIV-1-infected patients participating 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. Assessment visits are recommended according to local, generally accepted standards of care, but not less frequently than every 6 months. 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): significant increase in viral load; treatment-limiting toxicity; loss to follow-up; withdrawal of consent by the patient; pregnancy; termination of the trial by the sponsor; DRV becomes commercially available for the adult patient, 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Janssen R&D Ireland.