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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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31 January 2017 |
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Main ID: |
NCT03027297 |
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Date of registration:
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19/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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Continued Access to Darunavir/Ritonavir (DRV/Rtv) in HIV-1 Infected Adults, Adolescents and Children Aged 3 Years and Above |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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133 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03027297 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Costa Rica
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Guatemala
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Malaysia
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Panama
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South Africa
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Thailand
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Contacts
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Name:
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Janssen Sciences Ireland UC Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen Sciences Ireland UC |
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Key inclusion & exclusion criteria
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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.
Age minimum:
3 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV-1 Infections
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Intervention(s)
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Drug: Darunavir
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Drug: Ritonavir
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Primary Outcome(s)
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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]
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Secondary ID(s)
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TMC114IFD3001
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CR017230
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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