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

ViiV Healthcare

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Rilpivirine (RPV); Drug: Dolutegravir (DTG); Drug: Lamivudine (3TC)

Study type: Observational

Funder types: Industry

Identifiers

NCT04019873

207859

Details and patient eligibility

About

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.

Enrollment: 774 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

774 participants in 3 patient groups

Treatment-naïve participants

Description:

Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for Human Immunodeficiency Virus (HIV) infection.

Treatment:

Drug: Lamivudine (3TC)

Drug: Dolutegravir (DTG)

Drug: Rilpivirine (RPV)

Stable switch participants

Description:

Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.

Treatment:

Drug: Lamivudine (3TC)

Drug: Dolutegravir (DTG)

Drug: Rilpivirine (RPV)

Prior virological failure participants

Description:

Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.

Treatment:

Drug: Lamivudine (3TC)

Drug: Dolutegravir (DTG)

Drug: Rilpivirine (RPV)