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

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

Sponsors

Lead Sponsor: ViiV Healthcare

Source ViiV Healthcare
Brief 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.

Overall Status Recruiting
Start Date November 18, 2019
Completion Date December 31, 2021
Primary Completion Date December 31, 2021
Study Type Observational
Primary Outcome
Measure Time Frame
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
Secondary Outcome
Measure Time Frame
Number of subjects with HIV RNA >200 c/mL after 24 weeks Week 24
Number of subjects with HIV RNA >200 c/mL after 48 weeks Week 48
Number of subjects with HIV RNA >200 c/mL after 96 weeks Week 96
Number of subjects with low level viremia Up to Week 96
Time to virologic suppression Up to Week 96
Time to virologic failure Up to Week 96
Number of subjects with resistance profile in case of virologic failure Up to Week 96
Number of subjects with stable switch while virologically suppressed Up to Week 96
Number of subjects with Switch after Failure Up to Week 96
Number of subjects switching for safety reasons Up to Week 96
Number of subjects with adverse events (AEs) and serious AEs (SAEs) Up to Week 96
cluster of differentiation (CD)4+ and CD8+ T cell counts Up to Week 96
CD4/CD8 ratio at each time point Up to Week 96
Number of factors associated with plasma HIV-RNA > 50 c/mL Up to Week 96
Enrollment 1
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dolutegravir (DTG)

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

Arm Group Label: Subjects receiving 2DR treatment

Intervention Type: Drug

Intervention Name: Lamivudine (3TC)

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

Arm Group Label: Subjects receiving 2DR treatment

Intervention Type: Drug

Intervention Name: Rilpivirine (RPV)

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

Arm Group Label: Subjects receiving 2DR treatment

Eligibility

Sampling Method: Non-Probability Sample

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Overall Official
Last Name Role Affiliation
GSK Clinical Trials Study Director ViiV Healthcare
Overall Contact

Last Name: US GSK Clinical Trials Call Center

Phone: 877-379-3718

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: GSK Investigational Site US GSK Clinical Trials Call Center 877-379-3718 [email protected] Marta Gutiérrez Principal Investigator
Location Countries

Spain

Verification Date

March 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Subjects receiving 2DR treatment

Description: Data will be collected from HIV positive male or female adult subjects who have started 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor from 2014.

Patient Data Yes
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov