MedTrace Logo

A Prospective, Non-interventional Study of the Use of Dolutegravir as Part of Combination Antiretroviral Therapy in Routine Daily Practice in Germany

NCT02076386 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 411

Last updated 2018-08-13

No results posted yet for this study

Summary

DOL-ART is a multi-center, prospective, non-interventional study of the use of doluetegravir as part of an antiretroviral combination therapy in routine daily practice in Germany. The primary study objective is a descriptive characterization of the frequency of therapeutic monitoring measures in HIV-infected patients under dolutegravir-containing ART in routine daily practice in Germany.

The study is designed to enroll approximately 400 patients. There are no protocol-mandated visits or procedures associated with the study. Each patient is expected to participate for a maximum of 3 years or until premature discontinuation (i.e., discontinuation of dolutegravir, due to death, withdrawal of consent, lost to follow-up).

Conditions

  • Infection, Human Immunodeficiency Virus

Interventions

DRUG

Dolutegravir

Prospective, non-interventional study of the use of doluetegravir as part of an antiretroviral combination therapy in routine daily practice in Germany. No drug will be provided. No study visits or procedures are mandated per protocol.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-04
Primary Completion
2017-07-05
Completion
2017-07-05

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02076386 on ClinicalTrials.gov