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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

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ClinicalTrials.gov Identifier: NCT01281813
Recruitment Status : Active, not recruiting
First Posted : January 24, 2011
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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).

Condition or disease Intervention/treatment Phase
HIV-1 Infections Drug: Darunavir Drug: Ritonavir Phase 3

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continued Access to Darunavir/Ritonavir (DRV/Rtv) in HIV-1 Infected Adults, Adolescents and Children Aged 3 Years and Above
Actual Study Start Date : August 8, 2011
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 001
Darunavir (DRV) 400 milligram (mg) tablet intake of 2 tablets once daily in combination with Ritonavir (rtv)
Drug: Darunavir
400 mg tablet, intake of 2 tablets once daily in combination with ritonavir
Experimental: 002
Darunavir 600 mg tablet intake of 1 tablet twice a day in combination with Ritonavir
Drug: Darunavir
600 mg tablet, intake of 1 tablet twice a day in combination with ritonavir
Experimental: 003
Ritonavir 100 mg capsule to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
Drug: Ritonavir
100 mg capsule, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
Experimental: 004
Ritonavir 100 mg tablet to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
Drug: Ritonavir
100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
Experimental: 005
Darunavir 375 mg composed via various tablets (2x 150mg DRV tablets + 1x 75mg DRV tablet) in combination with Ritonavir (1x 100mg rtv tablet) twice daily
Drug: Ritonavir
100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
Drug: 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
Experimental: 006
Darunavir 375 mg composed via various tablets (2x 150mg DRV tablets + 1x 75mg DRV tablet) in combination with Ritonavir oral solution 80 milligram per milliLitre (mg/mL) (dose dependant on weight) twice daily
Drug: 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
Drug: Ritonavir
Ritonavir oral solution as 80 mg/mL (dose dependant on weight) in combination with Darunavir twice daily
Experimental: 007
Darunavir 375 mg composed via various tablets (2x 150mg DRV tablets + 1x 75mg DRV tablet) in combination with Ritonavir powder for oral suspension prepared as 100mg/10mL (dose dependant on weight) twice daily
Drug: 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
Drug: Ritonavir
Ritonavir powder for oral suspension prepared as 100 mg/10 mL (dose dependant on weight) in combination with Darunavir
Experimental: 008
Darunavir oral suspension (dose dependant on weight) in combination with Ritonavir 100mg tablet twice daily
Drug: Ritonavir
100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
Drug: Darunavir
Darunavir oral suspension (dose dependant on weight) in combination with Ritonavir
Experimental: 009
Darunavir oral suspension (dose dependant on weight) in combination with Ritonavir oral solution as 80 mg/mL (dose dependant on weight) twice daily
Drug: Darunavir
Darunavir oral suspension (dose dependant on weight) in combination with Ritonavir
Drug: Ritonavir
Ritonavir oral solution as 80 mg/mL (dose dependant on weight) in combination with Darunavir twice daily
Experimental: 010
Darunavir oral suspension (dose dependent on weight) in combination with Ritonavir powder for oral suspension prepared as 100 mg/10 mL (dose dependent on weight) twice daily
Drug: Darunavir
Darunavir oral suspension (dose dependant on weight) in combination with Ritonavir
Drug: Ritonavir
Ritonavir powder for oral suspension prepared as 100 mg/10 mL (dose dependant on weight) in combination with Darunavir


Outcome Measures

Primary Outcome Measures :
  1. 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: Approximately up to 7 years ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281813


Locations
Brazil
Rio De Janeiro, Brazil
Costa Rica
San Jose, Costa Rica
Guatemala
Guatemala, Guatemala
Malaysia
Selangor, Malaysia
Panama
Panama, Panama
South Africa
Cape Town, South Africa
Cyrildene Johannesburg Gauteng, South Africa
Dundee, South Africa
Durban, South Africa
Johannesburg, South Africa
Pretoria N/A, South Africa
Soweto, South Africa
Westdene Johannesburg Gauteng, South Africa
Thailand
Bangkok, Thailand
Chiang Mai, Thailand
Khon Kaen, Thailand
Ukraine
Vinnitsa, Ukraine
Sponsors and Collaborators
Janssen Sciences Ireland UC
Investigators
Study Director: Janssen Sciences Ireland UC Clinical Trial Janssen Sciences Ireland UC
More Information

Responsible Party: Janssen Sciences Ireland UC
ClinicalTrials.gov Identifier: NCT01281813     History of Changes
Obsolete Identifiers: NCT03027297
Other Study ID Numbers: CR017230
TMC114IFD3001 ( Other Identifier: Janssen Sciences Ireland UC )
2017-000285-30 ( EudraCT Number )
First Posted: January 24, 2011    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Sciences Ireland UC:
TMC114IFD3001
TMC114
HIV
Darunavir
PREZISTA

Additional relevant MeSH terms:
Ritonavir
Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors