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

October 6, 2022 updated by: Janssen Sciences Ireland UC

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

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 darunavir in combination with low-dose ritonavir (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) and to provide DRV through this trial until the participants can switched to locally available DRV-based treatment regimens (that is commercially available and reimbursed, or accessible through another source [for example, access program or government program]) or to local standard of care, as appropriate.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 parent clinical trials TMC114-C211, TMC114-C214, TMC114-TiDP31-C229 or in the parent 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 based treatment regimen becomes commercially available for the patients and is reimbursed, or can be accessed through another source (for example, access program, government program) in the region the patient is living in or patients can be switched to local standard of care, as appropriate. A post-treatment follow-up contact is to be performed 4 weeks after the last dose of trial medication for patients with an ongoing adverse event, that discontinue the trial. 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. For most of the patients, their next visit will be the final visit with data collection thereafter visits and assessments will be performed per local standard of care and documented in the patient's medical records only. Investigators will continue to report serious adverse events (SAEs) possibly related to DRV/rtv and pregnancies to the sponsor using regular reporting.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
145

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients treated with DRV/rtv who have successfully completed the TMC114-C211, TMC114-C214, TMC114-TiDP31-C229 (parent) trial or the pediatric (parent) 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 (for example, 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Continued Treatment with DRV in Combination with rtv
HIV-1 infected children participants (aged less than [<] 12 years) will continue to receive darunavir (DRV) 200 to 600 milligrams (mg) as oral suspension twice daily (BID) along with ritonavir (rtv) 32 to 100 mg as oral solution/suspension BID. HIV-1 infected adolescent participants (aged 12-17 years) will continue to receive DRV 200 to 600 mg as oral suspension BID along with rtv 32 to 100 mg as oral solution/suspension BID. Dosing for children and adolescent participants will be based on body weight (per parent study TMC114-TiDP29-C232). HIV-1 infected adult participants (aged greater than or equal to [>=] 18 years) will continue to receive DRV 800 mg (2 tablets of 400 mg) orally every day (qd) along with rtv 100 mg tablet (per parent study TMC114-C211) or DRV 600 mg tablet orally BID along with rtv 100 mg tablet (per parent study TMC114-C214 or TMC114-TiDP31-C229).
Drug: Darunavir
Participants will receive darunavir (per parent study) as oral suspension.
Drug: Ritonavir
Participants will receive ritonavir (per parent study) as oral solution/suspension.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Serious Adverse Events
Time Frame: Up to 9 years 11 months
Adverse events (AEs): any untoward medical occurrence (any unfavorable and unintended sign [including an abnormal laboratory finding], symptom, or disease) that occurred in a participant administered a pharmaceutical product and which did not necessarily have causal relationship with study treatment. Serious adverse events (SAEs): any untoward medical occurrence at any dose resulted: death; was life threatening; requires inpatient hospitalization/prolongation of existing hospitalization; resulted in persistent/significant disability/incapacity or congenital anomaly/birth defect. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study were included in single arm and combined analysis was performed as planned in protocol because the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
Up to 9 years 11 months
Number of Participants With Adverse Events Leading to Study Drug Discontinuation
Time Frame: Up to 9 years 11 months
Adverse events (AEs) were defined as any untoward medical occurrence (any unfavorable and unintended sign [including an abnormal laboratory finding], symptom, or disease) that occurred in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study were included in single arm and combined analysis was performed as planned in protocol because the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
Up to 9 years 11 months
Number of Participants With Adverse Events Possibly Related to Darunavir/Ritonavir (DRV/Rtv) Treatment
Time Frame: Up to 9 years 11 months
Number of participants with adverse events possibly related to DRV/rtv treatment were reported. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study were included in single arm and combined analysis was performed as planned in protocol because the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
Up to 9 years 11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Sciences Ireland UC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 8, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 29, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 29, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR017230
  • TMC114IFD3001 (Other Identifier: Janssen Sciences Ireland UC)
  • 2017-000285-30 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

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