GSK1265744 (Cabotegravir, CAB) for Named Patient/Compassionate Use in HIV
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ClinicalTrials.gov Identifier: NCT03462810 |
Expanded Access Status :
Available
First Posted : March 13, 2018
Last Update Posted : May 21, 2021
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Tracking Information | |||||
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First Submitted Date | March 5, 2018 | ||||
First Posted Date | March 13, 2018 | ||||
Last Update Posted Date | May 21, 2021 | ||||
Descriptive Information | |||||
Brief Title | GSK1265744 (Cabotegravir, CAB) for Named Patient/Compassionate Use in HIV | ||||
Official Title | GSK1265744 (Cabotegravir, CAB) for Named Patient/Compassionate Use in HIV | ||||
Brief Summary | The goal of this compassionate use program is to provide a mechanism to supply Cabotegravir, CAB on an individual named patient basis for treatment of individuals who have no available treatment alternatives and/or limited treatment options (e.g., who are unable to participate in the Phase III clinical studies or do not qualify), and are in need of new drugs to construct an effective antiviral regimen and may require the use of parenterally administered drug given underlying medical conditions. You can access ViiV's Policy on Compassionate via https://us.viivhealthcare.com/media/124424/viivs-external-policy-on-cup_final-version_23feb2017.pdf. | ||||
Detailed Description | Not Provided | ||||
Study Type | Expanded Access | ||||
Expanded Access Type | Individual Patients | ||||
Condition | Infection, Human Immunodeficiency Virus | ||||
Intervention | Drug: cabotegravir, CAB
open label investigational product
Other Names:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Expanded Access Status | Available | ||||
Eligibility Criteria | Inclusion Criteria:
NOTE: all female patients of reproductive potential should use every precaution to prevent pregnancy including either complete abstinence from intercourse from 2 weeks prior to administration of CAB, throughout receipt of CAB and for at least 52 weeks after discontinuation of CAB LA; or use of one of the following methods of highly reliable contraception:
These allowed methods of contraception are only effective when used consistently/correctly and in accordance with the product label. The investigator is responsible for ensuring that patients understand how to properly use these methods of contraception.
Exclusion Criteria:
NOTE: Patients should not be treated via the named patient/compassionate use program if they are eligible and/or able to participate in any of the Phase III clinical trials of CAB and the patient is suitable for participation in such clinical trials. In that instance (assuming consent is obtained) the patient should preferentially be enrolled into the ongoing clinical trial to allow detailed data collection. In accordance with national requirements patients should not be treated in the named patient/compassionate use program if they have responded to previous treatment with CAB in another clinical trial without review and prior approval by the VSLC. |
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Contacts |
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Listed Location Countries | Not Provided | ||||
Removed Location Countries | Canada, France, Portugal, Switzerland, United Kingdom, United States | ||||
Administrative Information | |||||
NCT Number | NCT03462810 | ||||
Other Study ID Numbers | 205741 | ||||
Current Responsible Party | ViiV Healthcare | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | ViiV Healthcare | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | ViiV Healthcare | ||||
Verification Date | October 2020 |