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

Sponsor

Janssen Sciences Ireland UC (Industry)

Overall Status

Completed

CT.gov ID

NCT01281813

Collaborator

(none)

145

Enrollment

Locations

Arms

118.7

Actual Duration (Months)

8.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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 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.

Condition or Disease	Intervention/Treatment	Phase
HIV-1 Infections	Drug: Darunavir Drug: Ritonavir Drug: Darunavir Drug: Ritonavir Drug: Darunavir Drug: Darunavir Drug: Ritonavir 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 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 Design

Study Type:

Interventional

Actual Enrollment :

145 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 :

Aug 8, 2011

Actual Primary Completion Date :

Jun 29, 2021

Actual Study Completion Date :

Jun 29, 2021

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 (2x150mg 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 dependent 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 dependent 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 dependent 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 dependent on weight) in combination with Darunavir
Experimental: 008 Darunavir oral suspension (dose dependent 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 dependent on weight) in combination with Ritonavir
Experimental: 009 Darunavir oral suspension (dose dependent on weight) in combination with Ritonavir oral solution as 80 mg/mL (dose dependent on weight) twice daily	Drug: Darunavir Darunavir oral suspension (dose dependent on weight) in combination with Ritonavir Drug: Ritonavir Ritonavir oral solution as 80 mg/mL (dose dependent 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 dependent on weight) in combination with Ritonavir Drug: Ritonavir Ritonavir powder for oral suspension prepared as 100 mg/10 mL (dose dependent on weight) in combination with Darunavir

Outcome Measures

Primary Outcome Measures

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 [Up to 9.5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	Country
1	Rio De Janeiro	Brazil
2	San Jose	Costa Rica
3	Guatemala	Guatemala
4	Selangor	Malaysia
5	Panama	Panama
6	Cape Town	South Africa
7	Cyrildene Johannesburg Gauteng	South Africa
8	Dundee	South Africa
9	Durban	South Africa
10	Johannesburg	South Africa
11	Pretoria N/a	South Africa
12	Soweto	South Africa
13	Westdene Johannesburg Gauteng	South Africa
14	Bangkok	Thailand
15	Chiang Mai	Thailand
16	Khon Kaen	Thailand
17	Vinnitsa	Ukraine