NCT04019873

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 774 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	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.
DRUG	Lamivudine (3TC)	3TC is a nucleoside reverse transcriptase inhibitor. Subjects receiving 3TC as a part of 2DR treatment will be included in the study.
DRUG	Rilpivirine (RPV)	RPV is a non-nucleoside reverse transcriptase inhibitor. Subjects receiving RPV as part of 2DR treatment will be included in the study.

Timeline

• Start date: 2019-11-18
• Primary completion: 2023-04-14
• Completion: 2023-12-05
• First posted: 2019-07-15
• Last updated: 2025-01-22
• Results posted: 2025-01-22

Locations

1 site across 1 country: Spain