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Study sponsor: ViiV Healthcare
Studies listed Globally sponsored interventional phase II-IV clinical studies listed on www.viiv-clinicaltrialregister.com that study ViiV Healthcare medicines in people living with HIV.

Other studies where data have been provided to researchers.

Where feasible, ViiV Healthcare will list studies that do not meet these criteria but add significant information to the understanding of a licensed medicine.
Exceptions The current list does not include compounds whose development has been terminated.

For studies that are not listed, ViiV Healthcare will assess the feasibility of data provision as part of the review of enquiries.
When studies are listed After the medicine studied has been approved by regulators (first approval) or terminated from development and the study has been accepted for publication.
Additional conditions for data access When patients agreed to take part in ViiV Healthcare clinical studies they gave permission (through informed consent) to use their data to study the medicine or disease ViiV Healthcare (or its parent companies) were researching. Further research must therefore study the medicine or disease that was researched in the original studies.

For studies ViiV Healthcare conduct from 2014, patients will be asked to give permission for broader research so other research may be possible with data from these studies.
Datasets and documents provided Where available, the following anonymised patient level data and information is provided for each clinical study.
Raw dataset. This is the data collected for each patient in the clinical study.
Analysis-ready dataset. This is the dataset used for ViiV Healthcare’s analysis.
Protocol with any amendments. This describes the objectives, design, methodology, statistical considerations, and organisation of a clinical study.
Annotated case report form. This is a blank case report form with descriptions of the data collected and how they are described in the dataset.
Reporting and analysis plan. This describes methods of analysis, procedures for data handling and data displays (figures and tables) ViiV Healthcare used for the study.
Dataset specifications. This is the meta-data which describes the datasets e.g., variable labels, variable descriptions, code lists, formats.
Clinical study report. This is the report of efficacy and safety data from the study. It forms the basis of submissions to regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Appendices which include patient level data are not included as these data are provided in the datasets ViiV Healthcare provide. To protect research participants’ privacy and confidentiality, case narratives are not routinely included. They may be provided where they are needed for a specific research proposal, provided research participants’ privacy can be protected.
Enquiries Researchers can enquire about the availability of data from ViiV Healthcare clinical studies that are not listed on the site before they submit a research proposal.
Access to study documents without patient-level data Researchers can enquire about access to clinical study documents by completing the online enquiry form.
Review criteria for enquiries Whether the studies have been published or accepted for publication and whether they researched authorised medicines (for approved uses). It is ViiV Healthcare policy to provide access to patient level data after authorisation of the medicine (or the decision has been taken to terminate development of the medicine) and acceptance of the study for publication in the scientific literature.

Whether ViiV Healthcare are able to provide the requested data. For example, the majority of non-interventional (or observational) studies use data from third party databases under licence agreements which prevent ViiV Healthcare from providing access to the data. Researchers can access data directly from these third party databases under similar agreements.

Whether ViiV Healthcare have the legal authority to provide the data. For example, ViiV Healthcare may not have the legal authority because the medicine has been out-licensed to another company.

Whether ViiV Healthcare consider it feasible to anonymise the data without compromising the privacy and confidentiality of research participants.

Whether ViiV Healthcare consider that there are any practical constraints to providing access to the data. For example, there may be issues related to the size of databases from genetic studies.

The resources (costs) for ViiV Healthcare to retrieve data and documents from repositories and archives, anonymise data, and redact personally identifiable information from relevant documents. In some cases, particularly for older studies, the costs could be considerable and ViiV Healthcare may turn down requests on this basis.
Anonymisation standards
Clinical study register http://www.ViiV-clinicalstudyregister.com/