NCT04019873Completed
'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors Plus a Reverse Transcriptase Inhibitor
Source: ClinicalTrials.gov · Last updated 22 Jan 2025
Brief summary (registry, in English)
Dolutegravir (DTG) is a well-tolerated 2nd generation integrase strand transfer inhibitor (INSTI); rilpivirine (RPV) is a well-tolerated non- nucleoside reverse transcriptase inhibitors (NNRTI) and lamivudine (3TC) is a nucleoside reverse transcriptase inhibitors (NRTIs). This study aims to gather the real-world evidence to evaluate effectiveness of the two-drug regimen (2DR). This is a multi-site observational study in subjects who have started and/or who plan to initiate 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor. The study does not require any changes to the routine standard of care that subjects receive. Approximately 500 eligible subjects will be included from potential investigational sites across Europe and data from them will be collected either retrospectively or prospectively.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 774 (actual)
- First submitted
- 19 Jul 2018
- Start date
- 18 Nov 2019
- Primary completion date
- 14 Apr 2023
- Lead sponsor
- ViiV Healthcare
- Diseases
- HIV
- NCT number
- NCT04019873
What you commit to
- Study type: Observational
- Participants enrolled: 774
- From 18 Nov 2019 to the primary completion date, 14 Apr 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- No specific exclusion criteria
Who the study is looking for
- HIV positive male or female subjects aged 18 years or over and who have started 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor from 2014 onwards as a first-line treatment among naïve subjects, or a switching option for those with HIV RNA suppression on current treatment (stable switches), or a second-line treatment for those with virological failure on prior treatment.
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GSK Investigational Site Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.