Clinical Trials Directory

Trials / Completed

CompletedNCT03518060

Dolutegravir/Rilpivirine, Antiretroviral Efficacy Study Using Real-world Data in Subjects With Human Immunodeficiency Virus (HIV)-1

Durability of Antiretroviral Suppression and the Real World Clinical Profile of the Novel 2-Drug Regimen Juluca, a Onepill-Regimen Consisting of Dolutegravir and Rilpivirine, in Routine Clinical Care in Germany

Status
Completed
Phase
Study type
Observational
Enrollment
209 (actual)
Sponsor
ViiV Healthcare · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This was a prospective, non-interventional, single-arm, multi-center study aimed at gathering real-world data on JULUCA use in routine clinical care in Germany, to supplement clinical trial data to further improve/optimize care in HIV positive participants in Germany. Approximately 250 virologically suppressed HIV positive participants on stable antiretroviral therapy (ART) were included in the study at the discretion of treating physician. Eligible participants were followed up for approximately 3 years and data was collected during routine clinical care.

Conditions

Interventions

TypeNameDescription
DRUGJULUCAJULUCA is a combination of dolutegravir (INSTI) and rilpivirine (NNRTI).

Timeline

Start date
2018-06-25
Primary completion
2023-05-14
Completion
2023-05-14
First posted
2018-05-08
Last updated
2024-10-16
Results posted
2024-10-16

Locations

23 sites across 1 country: Germany

Source: ClinicalTrials.gov record NCT03518060. Inclusion in this directory is not an endorsement.

Dolutegravir/Rilpivirine, Antiretroviral Efficacy Study Using Real-world Data in Subjects With Human Immunodeficiency Vi (NCT03518060) · Clinical Trials Directory