HIV-1 InfectionsPhase 2NCT01138605
TMC114-TiDP29-C232 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir (Rtv) for Children Coming From Any of the Three Ongoing Tibotec Sponsored Pediatric Studies With DRV
A Phase 2 study testing Darunavir and Ritonavir in people with HIV-1 Infections, run by Janssen Sciences Ireland UC at 13 sites in 8 countries.
Trial summary
The primary objective of this study is to continue to provide Darunavir (DRV) to pediatric patients who previously received DRV in any of three pediatric clinical studies sponsored by Tibotec Pharmaceuticals and continue to benefit from using it, in countries where DRV is not yet commercially available for the… Read more about this study
- Who is it for?
- Ages 3 to 99 years
- Conditions the study is for
- HIV-1 Infections
- What is being tested?
- Darunavir and Ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 13 sitesin 8 countries
- Study dates
- 13 Oct 2010to 23 Nov 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient has completed the TMC114-C212, TMC114-TiDP29-C228 or TMC114-TiDP29-C230 study and continues to benefit from DRV
- DRV is not commercially available, not reimbursed or cannot be accessed through another way
- signed informed consent by parents/caregivers or assent by the patient is available prior to inclusion
Who cannot join
- Any condition or active clinically significant disease (such as pancreas problems or cardiac problems) endangering the patient safety while being enrolled in the study
- Previously demonstrated clinically significant allergy or hypersensitivity to the study medication
- Pregnancy or breastfeeding female patients
- Specific criteria will be applicable for girls having had their first menses and for girls and boys having reached the age of sexual activity
Trial locations and contacts
13 sites in 8 countries.
13 sites in 8 countries
Brazil3 sites
Study site
Ribeirão Preto
Study site
Rio de Janeiro
Study site
São Paulo
South Africa3 sites
Study site
Durban Kwazulu Natal
Study site
Gauteng
Study site
Johannesburg
Argentina2 sites
Study site
Buenos Aires
Study site
Ciudad Autonoma Buenos Aires
About this study
Official title: Continued Access to DRV/Rtv in HIV-1 Infected Children and Adolescents (Rollover Patients From C212, C228, C230)
The primary objective of this study is to continue to provide Darunavir (DRV) to pediatric patients who previously received DRV in any of three pediatric clinical studies sponsored by Tibotec Pharmaceuticals and continue to benefit from using it, in countries where DRV is not yet commercially available for the pediatric patient, is not reimbursed or cannot be accessed through another source (like access program or government program).
Read the detailed description
This study has the aim to continue the provision of DRV and rtv to pediatric patients that continue to benefit from treatment with it after participation in any of three ongoing pediatric studies sponsored by Tibotec Pharmaceuticals. In addition, information on the safety of DRV and rtv in combination with other antiretroviral therapies will be assessed. At the baseline visit, inclusion and exclusion criteria will be checked to confirm eligibility. Once eligible, patients will continue treatment either on the once daily dose regimen (when coming from the TMC114-TiDP29-C230 study) or a twice daily regimen (when coming from the TMC114-C212 or TMC114-TiDP29-C228 studies). Assessments and visit frequency will take place as per local standard of care but are desirable every 3 months. The interval between two visits should not exceed 6 months. Pregnancy testing for girls having had their first menses is foreseen. In addition, it is desirable that testing includes efficacy assessments (immunology and plasma viral load) and laboratory safety assessments (hematology, biochemistry including pancreatic amylase (if available) or lipase and lipid analysis). Serious Adverse Events and certain selected Adverse Events will be collected. 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 or assent by the patient or withdrawal of consent by the caregiver, pregnancy, termination of the trial by the sponsor, when Darunavir becomes commercially available, is reimbursed or can be accessed through another source (as there are access program or government program) in the region the patient is living in. The sponsor advises participating centers to plan the study visits every 3 months but frequency will depend on local practice and standard of care. The sponsor has also foreseen in the study protocol a guidance on specific safety assessments to be performed as well as detailed instructions on how to deal with specific toxicities and undesirable effects. However local practice will prevail and the assessments performed may vary depending on the region the patient is participating in. Intake of study medication will happen once daily or twice daily, depending on what the patient took in the original pediatric trial. For the twice daily regimen, the regimen may be adjusted as the patient gains weight. The adult dosage regimen of 600/100 mg DRV/rtv may be administered as of 40 kg of body weight. Depending on the history of the patient, following dosages may be administered: DRV oral suspension (100mg DRV/ml), DRV tablets 75 mg, 150 mg, 600 mg, all for twice daily intake. DRV 400 mg for the once daily 800 mg intake (2 tablets per intake).DRV intake will be combined with rtv in oral suspension (80 mg rtv/ml), capsule or tablet (both 100 mg).
- Conditions
- HIV-1 Infections
- Being tested
- Darunavir, Ritonavir
- Keywords
- TMC114, TMC114-TiDP29-C232, TMC114-C232, Darunavir, PREZISTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarunavirDrug
600mg composed via oral solution or various tablets, twice daily in combination with ritonavir, for body weight as of 40 kg
RitonavirDrug
Liquid formulation, 80 mg/ml, taken in combination with Darunavir
RitonavirDrug
100 mg capsule, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
DarunavirDrug
Oral suspension 100 mg/ml, 20 mg/kg twice daily in combination with ritonavir for body weight between 10 and 20 kg
RitonavirDrug
100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
DarunavirDrug
375 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 20 and 30 kg
DarunavirDrug
450 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 30 and 40 kg
DarunavirDrug
400 mg tablet, intake of 2 tablets once daily in combination with ritonavir
RitonavirDrug
100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
DarunavirDrug
375 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 20 and 30 kg
RitonavirDrug
Liquid formulation, 80 mg/ml, taken in combination with Darunavir
DarunavirDrug
450 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 30 and 40 kg
DarunavirDrug
600mg composed via oral solution or various tablets, twice daily in combination with ritonavir, for body weight as of 40 kg
RitonavirDrug
100 mg capsule, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
RitonavirDrug
Ritonavir powder for oral suspension 10 mg/mL taken in combination with Darunavir.
| Study group | Role | What they receive |
|---|---|---|
| 005 | Experimental | Darunavir 400 mg tablet intake of 2 tablets once daily in combination with ritonavir Receives: Drug: Darunavir |
| 006 | Experimental | Ritonavir Liquid formulation 80 mg/ml taken in combination with Darunavir Receives: Drug: Darunavir; Drug: Ritonavir |
| 007 | Experimental | Ritonavir 100 mg capsule to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule Receives: Drug: Darunavir; Drug: Ritonavir |
| 008 | Experimental | Ritonavir 100 mg tablet to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule Receives: Drug: Darunavir; Drug: Ritonavir |
| 001 | Experimental | Darunavir Oral suspension 100 mg/ml 20 mg/kg twice daily in combination with ritonavir for body weight between 10 and 20 kg Receives: Drug: Darunavir |
| 002 | Experimental | Darunavir 375 mg composed via oral solution or various tablets twice daily in combination with ritonavir for body weight between 20 and 30 kg Receives: Drug: Ritonavir; Drug: Darunavir |
| 003 | Experimental | Darunavir 450 mg composed via oral solution or various tablets twice daily in combination with ritonavir for body weight between 30 and 40 kg Receives: Drug: Ritonavir; Drug: Darunavir |
| 004 | Experimental | Darunavir 600mg composed via oral solution or various tablets twice daily in combination with ritonavir for body weight as of 40 kg Receives: Drug: Ritonavir; Drug: Darunavir |
| 009 | Experimental | Ritonavir powder for oral suspension 10 mg/mL taken in combination with Darunavir. Receives: Drug: Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of DRV/rtv in combination with other ARVs will be summarized in terms of Mortality, all Serious Adverse Events,Adverse events leading to discontinuation and Adverse Events at least possibly related to the DRV treatment
Measured: Variable, up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study start13 Oct 2010
- Primary completion23 Nov 2017
- Study completion23 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Sciences Ireland UC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Sciences Ireland UC Clinical Trial, Study director, Janssen Sciences Ireland UC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138605
- Sponsor's protocol ID
- CR016768
- Other IDs
- TMC114-TiDP29-C232, 2009-017013-29, 2009
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2010
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Publications
Violari A, Masenya M, Blanche S, Vanveggel S, Hufkens V, Chetty P, Opsomer M. The DIANA Study: Continued Access to Darunavir/Ritonavir (DRV/r) and Long-Term Safety Follow-Up in HIV-1-Infected Pediatric Patients Aged 3 to < 18 Years. Drug Saf. 2021 Apr;44(4):439-446. doi: 10.1007/s40264-020-01032-0. Epub 2020 Dec 24.
PubMed 33367975
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continued Access to DRV/Rtv in HIV-1 Infected Children and Adolescents (Rollover Patients From C212, C228, C230)
- ClinicalTrials.gov ID
- NCT01138605
- Acronym / sponsor ID
- CR016768
- Conditions
- HIV-1 Infections
- Keywords
- TMC114, TMC114-TiDP29-C232, TMC114-C232, Darunavir, PREZISTA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Janssen Sciences Ireland UCIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2010 (actual)
- Primary completion
- 23 Nov 2017 (actual)
- Study completion
- 23 Nov 2017 (actual)
- First posted
- 7 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to continue to provide Darunavir (DRV) to pediatric patients who previously received DRV in any of three pediatric clinical studies sponsored by Tibotec Pharmaceuticals and continue to benefit from using it, in countries where DRV is not yet commercially available for the pediatric patient, is not reimbursed or cannot be accessed through another source (like access program or government program).
Detailed description
This study has the aim to continue the provision of DRV and rtv to pediatric patients that continue to benefit from treatment with it after participation in any of three ongoing pediatric studies sponsored by Tibotec Pharmaceuticals. In addition, information on the safety of DRV and rtv in combination with other antiretroviral therapies will be assessed. At the baseline visit, inclusion and exclusion criteria will be checked to confirm eligibility. Once eligible, patients will continue treatment either on the once daily dose regimen (when coming from the TMC114-TiDP29-C230 study) or a twice daily regimen (when coming from the TMC114-C212 or TMC114-TiDP29-C228 studies). Assessments and visit frequency will take place as per local standard of care but are desirable every 3 months. The interval between two visits should not exceed 6 months. Pregnancy testing for girls having had their first menses is foreseen. In addition, it is desirable that testing includes efficacy assessments (immunology and plasma viral load) and laboratory safety assessments (hematology, biochemistry including pancreatic amylase (if available) or lipase and lipid analysis). Serious Adverse Events and certain selected Adverse Events will be collected. 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 or assent by the patient or withdrawal of consent by the caregiver, pregnancy, termination of the trial by the sponsor, when Darunavir becomes commercially available, is reimbursed or can be accessed through another source (as there are access program or government program) in the region the patient is living in. The sponsor advises participating centers to plan the study visits every 3 months but frequency will depend on local practice and standard of care. The sponsor has also foreseen in the study protocol a guidance on specific safety assessments to be performed as well as detailed instructions on how to deal with specific toxicities and undesirable effects. However local practice will prevail and the assessments performed may vary depending on the region the patient is participating in. Intake of study medication will happen once daily or twice daily, depending on what the patient took in the original pediatric trial. For the twice daily regimen, the regimen may be adjusted as the patient gains weight. The adult dosage regimen of 600/100 mg DRV/rtv may be administered as of 40 kg of body weight. Depending on the history of the patient, following dosages may be administered: DRV oral suspension (100mg DRV/ml), DRV tablets 75 mg, 150 mg, 600 mg, all for twice daily intake. DRV 400 mg for the once daily 800 mg intake (2 tablets per intake).DRV intake will be combined with rtv in oral suspension (80 mg rtv/ml), capsule or tablet (both 100 mg).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 005 | Experimental | Drug: DarunavirDarunavir 400 mg tablet intake of 2 tablets once daily in combination with ritonavir |
| 006 | Experimental | Drug: Darunavir, Drug: RitonavirRitonavir Liquid formulation 80 mg/ml taken in combination with Darunavir |
| 007 | Experimental | Drug: Darunavir, Drug: RitonavirRitonavir 100 mg capsule to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule |
| 008 | Experimental | Drug: Darunavir, Drug: RitonavirRitonavir 100 mg tablet to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule |
| 001 | Experimental | Drug: DarunavirDarunavir Oral suspension 100 mg/ml 20 mg/kg twice daily in combination with ritonavir for body weight between 10 and 20 kg |
| 002 | Experimental | Drug: Ritonavir, Drug: DarunavirDarunavir 375 mg composed via oral solution or various tablets twice daily in combination with ritonavir for body weight between 20 and 30 kg |
| 003 | Experimental | Drug: Ritonavir, Drug: DarunavirDarunavir 450 mg composed via oral solution or various tablets twice daily in combination with ritonavir for body weight between 30 and 40 kg |
| 004 | Experimental | Drug: Ritonavir, Drug: DarunavirDarunavir 600mg composed via oral solution or various tablets twice daily in combination with ritonavir for body weight as of 40 kg |
| 009 | Experimental | Drug: RitonavirRitonavir powder for oral suspension 10 mg/mL taken in combination with Darunavir. |
Who may qualify
- Ages
- 3 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient has completed the TMC114-C212, TMC114-TiDP29-C228 or TMC114-TiDP29-C230 study and continues to benefit from DRV
- DRV is not commercially available, not reimbursed or cannot be accessed through another way
- signed informed consent by parents/caregivers or assent by the patient is available prior to inclusion
Key exclusion criteria (4 listed)
- Any condition or active clinically significant disease (such as pancreas problems or cardiac problems) endangering the patient safety while being enrolled in the study
- Previously demonstrated clinically significant allergy or hypersensitivity to the study medication
- Pregnancy or breastfeeding female patients
- Specific criteria will be applicable for girls having had their first menses and for girls and boys having reached the age of sexual activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Darunavir600mg composed via oral solution or various tablets, twice daily in combination with ritonavir, for body weight as of 40 kg | Drug | 008 |
| RitonavirLiquid formulation, 80 mg/ml, taken in combination with Darunavir | Drug | 002 |
| Ritonavir100 mg capsule, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule | Drug | 003 |
| DarunavirOral suspension 100 mg/ml, 20 mg/kg twice daily in combination with ritonavir for body weight between 10 and 20 kg | Drug | 005 |
| Ritonavir100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule | Drug | 004 |
| Darunavir375 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 20 and 30 kg | Drug | 006 |
| Darunavir450 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 30 and 40 kg | Drug | 007 |
| Darunavir400 mg tablet, intake of 2 tablets once daily in combination with ritonavir | Drug | 001 |
| Ritonavir100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule | Drug | 008 |
| Darunavir375 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 20 and 30 kg | Drug | 002 |
| RitonavirLiquid formulation, 80 mg/ml, taken in combination with Darunavir | Drug | 006 |
| Darunavir450 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 30 and 40 kg | Drug | 003 |
| Darunavir600mg composed via oral solution or various tablets, twice daily in combination with ritonavir, for body weight as of 40 kg | Drug | 004 |
| Ritonavir100 mg capsule, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule | Drug | 007 |
| RitonavirRitonavir powder for oral suspension 10 mg/mL taken in combination with Darunavir. | Drug | 009 |
Primary outcome
Safety and tolerability of DRV/rtv in combination with other ARVs will be summarized in terms of Mortality, all Serious Adverse Events,Adverse events leading to discontinuation and Adverse Events at least possibly related to the DRV treatment
Time frame: Variable, up to 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Derived from this study: PubMed 33367975Violari A, Masenya M, Blanche S, Vanveggel S, Hufkens V, Chetty P, Opsomer M. The DIANA Study: Continued Access to Darunavir/Ritonavir (DRV/r) and Long-Term Safety Follow-Up in HIV-1-Infected Pediatric Patients Aged 3 to < 18 Years. Drug Saf. 2021 Apr;44(4):439-446. doi: 10.1007/s40264-020-01032-0. Epub 2020 Dec 24.
- Continued access to darunavir/ritonavir (DRV/rtv) in HIV-1 infected children and adolescents aged 3 years and aboveLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Sciences Ireland UC Clinical Trial study director
Janssen Sciences Ireland UC
13 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Darunavir and Ritonavir in people with HIV-1 Infections, run by Janssen Sciences Ireland UC at 13 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Brazil, South Africa, Argentina, France, India and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of DRV/rtv in combination with other ARVs will be summarized in terms of Mortality, all Serious Adverse Events,Adverse events leading to discontinuation and Adverse Events at least possibly related to the DRV treatment (time frame: Variable, up to 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01138605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.