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

NCT01281813 | Completed Phase 3 Results

• 3 other identifiers: CR017230TMC114IFD30012017-000285-30
• Study Type: interventional
• Target: 145
• Locations: 8 countries
• Sites: 17

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 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.

Conditions

HIV-1 Infections

Keywords

TMC114IFD3001; TMC114; HIV; Darunavir; PREZISTA

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Serious Adverse Events

  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

  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

  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

Study Arms (1)

Continued Treatment with DRV in Combination with rtv

EXPERIMENTAL

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; Drug: Ritonavir

Interventions

Darunavir DRUG

Participants will receive darunavir (per parent study) as oral suspension.

Continued Treatment with DRV in Combination with rtv

Ritonavir DRUG

Participants will receive ritonavir (per parent study) as oral solution/suspension.

Continued Treatment with DRV in Combination with rtv

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Sciences Ireland UC: lead

Study Sites (17)

Unknown Facility

Rio de Janeiro, Brazil

Location

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San José, Costa Rica

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Guatemala City, Guatemala

Location

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Kuala Selangor, Malaysia

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Panama City, Panama

Location

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Cape Town, South Africa

Location

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Cyrildene Johannesburg Gauteng, South Africa

Location

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Dundee, South Africa

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Durban, South Africa

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Johannesburg, South Africa

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Pretoria, South Africa

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Soweto, South Africa

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Westdene Johannesburg Gauteng, South Africa

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Bangkok, Thailand

Location

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Chiang Mai, Thailand

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Khon Kaen, Thailand

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Unknown Facility

Vinnitsa, Ukraine

Location

MeSH Terms

Interventions

Darunavir; Ritonavir

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles

Results Point of Contact

• Title: Director Clinical Development
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Sciences Ireland UC Clinical Trial

  Janssen Sciences Ireland UC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2010
• First Posted: January 24, 2011
• Study Start: August 8, 2011
• Primary Completion: July 29, 2021
• Study Completion: July 29, 2021
• Last Updated: October 31, 2022
• Results First Posted: October 31, 2022

Record last verified: 2022-10

Locations

PA (1); GU (1); TH (3); CO (1); BR (1); ZA (8); UA (1); MY (1)