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NCT Number: NCT02076386

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

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).

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Key information

Conditions

Infection, Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Freiburg im Breisgau, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented HIV infection
  • Age ≥ 18 years
  • Decision for the first initiation of dolutegravir as part of an ART by the attending physician irrespective of inclusion in this observational study
  • Prior to the start of this study, the patient must have been receiving a dolutegravir-containing ART for at least 4 weeks

Exclusion criteria

  • Discontinuation of dolutegravir as part of an ART prior to the start of the study documentation
  • Participation in a clinical trial during this study
  • Participation in a clinical trial or compassionate use program with dolutegravir being or having been part of the investigational medication

Treatment and study plan

Dolutegravir

Drug

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.

Primary outcomes

  1. Frequency of therapeutic monitoring measures in HIV-infected patients

    Time frame: up to 3 years

    Descriptive characterization of the frequency of therapeutic monitoring measures in HIV-infected patients under dolutegravir-containing ART in routine daily practice in Germany.

Secondary outcomes

  1. Type of the therapeutic monitoring measures

    Time frame: up to 3 years

  2. Number of participants with Serious Adverse Events and drug-related adverse events as a measure of safety and tolerability

    Time frame: up to 3 years

    To evaluate the frequency and type of serious adverse events and drug-related adverse events in patients treated with dolutegravir.

  3. Efficacy

    Time frame: from start of dolutegravir up to 3 years

    Defined as viral load < 50 copies/ml

  4. Resistance profile

    Time frame: from start of dolutegravir up to 3 years

    To characterise resistance profile in case of virological failure

  5. Patient satisfaction

    Time frame: Up to 3 years from baseline

    To evaluate the change in patient satisfaction relative to baseline in patients treated with dolutegravir

  6. Reasons for selecting dolutegravir-containing ART

    Time frame: Baseline

  7. Reasons for discontinuing dolutegravir-containing ART

    Time frame: Up to 3 years after baseline

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Acronym: DOL-ART

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 3, 2014
Registry last updated
Aug 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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