VIIV-201584

Study Sponsor: ViiV

Study Title

A Phase III, Randomized, Multicenter, Parallel-group, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch from an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naive Adult Participants

Medicine or Vaccine (generic name)

cabotegravir; rilpivirine

Sponsor Identification Number

201584

Trial Registry Identification Number(#'s)

NCT02938520 2016-001646-25

Medical Condition

Infection, Human Immunodeficiency Virus

Phase

Phase 3

Link to study details on the ViiV Clinical Study Register

https://www.viiv-studyregister.com/en/study/?id=201584

Link to study details on ClinicalTrials.gov (if available)

http://clinicaltrials.gov/show/NCT02938520

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=/2016-001646-25

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

A sister study 201585 was conducted. This study is still ongoing, however data related to the publication(s) is available. The data for this study is available in CDISC format.

Date Added to this Site

May 2020