Clinical trial

'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors Plus a Reverse Transcriptase Inhibitor

NCT04019873

Name

207859

Description

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.

Trial arms

Trial start

2019-11-18

Estimated PCD

2023-01-31

Trial end

2023-01-31

Status

Completed

Treatment

Dolutegravir (DTG)

DTG is a 2nd generation integrase strand transfer inhibitor. Subjects receiving DTG as a part of 2DR treatment will be included in the study.

Arms:

Subjects receiving 2DR treatment

Lamivudine (3TC)

3TC is a nucleoside reverse transcriptase inhibitor. Subjects receiving 3TC as a part of 2DR treatment will be included in the study.

Arms:

Subjects receiving 2DR treatment

Rilpivirine (RPV)

RPV is a non-nucleoside reverse transcriptase inhibitor. Subjects receiving RPV as part of 2DR treatment will be included in the study.

Arms:

Subjects receiving 2DR treatment

Size

Primary endpoint

Number of treatment-naïve subjects with human immunodeficiency virus ribonucleic acid (HIV-RNA) levels <50 copies/milliliter (c/mL) at Week 24

Week 24

Number of treatment-naïve subjects with human immunodeficiency virus ribonucleic acid (HIV-RNA) levels <50 c/mL at Week 48

Week 48

Number of treatment-naïve subjects with human immunodeficiency virus ribonucleic acid (HIV-RNA) levels <50 c/mL at Week 96

Week 96

Number of subjects who lose virologic control within the first 24 weeks after switching to a 2-DR

Week 24

Number of subjects who lose virologic control within the first 48 weeks after switching to a 2-DR

Week 48

Number of subjects who lose virologic control within the first 96 weeks after switching to a 2-DR

Week 96

Number of treatment-experienced subjects with HIV-RNA levels <50 c/mL at Week 24

Week 24

Number of treatment-experienced subjects with HIV-RNA levels <50 c/mL at Week 48

Week 48

Number of treatment-experienced subjects with HIV-RNA levels <50 c/mL at Week 96

Week 96

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * No specific exclusion criteria

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1, 'type': 'ACTUAL'}}

Updated at

2023-11-13

1 organization

3 products

1 indication

Organization

Product

Indication

Product

Product