N/A
N=774
'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors Plus a Reverse Transcriptase Inhibitor
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT04019873 ↗Enrolled (actual)
774
Serious AEs
0.4%
Results posted
Jan 2025
Primary outcome: Primary: Number of Treatment-naïve Participants With Human Immunodeficiency Virus Ribonucleic Acid (HIV-RNA) Levels Less Than (<)50 Copies/Milliliter (c/mL) at 24 Weeks After 2DR (Two-drug Regimen) Initiation — 19 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Dolutegravir (DTG) (Drug); Lamivudine (3TC) (Drug); Rilpivirine (RPV) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ViiV Healthcare
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment-naïve Participants With Human Immunodeficiency Virus Ribonucleic Acid (HIV-RNA) Levels Less Than (<)50 Copies/Milliliter (c/mL) at 24 Weeks After 2DR (Two-drug Regimen) Initiation |
19 | — |
| PRIMARY Number of Treatment-naïve Participants With HIV-RNA Levels <50 c/mL at 48 Weeks After 2DR Initiation |
19 | — |
| PRIMARY Number of Treatment-naïve Participants With HIV-RNA Levels <50 c/mL at 96 Weeks After 2DR Initiation |
20 | — |
| PRIMARY Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 24 |
14 | — |
| PRIMARY Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 48 |
11 | — |
| PRIMARY Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 96 |
10 | — |
| PRIMARY Number of Treatment-naïve Participants Experiencing Virologic Failure (VF) [Up to 24 Weeks] |
— | — |
| PRIMARY Number of Treatment-naïve Participants Experiencing VF [Up to 48 Weeks] |
— | — |
| PRIMARY Number of Treatment-naïve Participants Experiencing VF [Up to 96 Weeks] |
— | — |
| PRIMARY Number of Stable Switch Participants With VF Within the First 24 Weeks |
1 | — |
| PRIMARY Number of Stable Switch Participants With VF Within the First 48 Weeks |
3 | — |
| PRIMARY Number of Stable Switch Participants With VF Within the First 96 Weeks |
10 | — |
| PRIMARY Number of Treatment-experienced Viremic Participants Experiencing VF [Up to 24 Weeks] |
— | — |
| PRIMARY Number of Treatment-experienced Viremic Participants Experiencing VF [Up to 48 Weeks] |
1 | — |
| PRIMARY Number of Treatment-experienced Viremic Participants Experiencing VF [Up to 96 Weeks] |
3 | — |
| SECONDARY Number of Participants With HIV RNA Levels >=200 c/mL After 24 Weeks, 48 Weeks and 96 Weeks |
0; 1; 2; 0; 1; 1 | — |
| SECONDARY Number of Participants With Low Level Viremia |
1; 6; 0; 0; 8; 0 | — |
| SECONDARY Time to Virologic Suppression Among Treatment-naïve Participants and Treatment-experienced Viremic Participants, Who Achieved Suppression |
NA; NA | — |
| SECONDARY Time to Virologic Failure in the Stable Switch Population |
NA | — |
| SECONDARY Number of Participants With Emergent Resistance Mutations Following Virologic Failure (VF) Events |
0; 0; 0 | — |
| SECONDARY Number of Participants Who Discontinue Their Baseline 2DR and Who Stable Switch to a Different Regimen While Virologically Suppressed (HIV RNA <50 Copies/mL) at Switch |
1; 35; 1 | — |
| SECONDARY Number of Participants Who Discontinue Their Baseline 2DR and Who Switch Following Virologic Failure |
0; 4; 1 | — |
| SECONDARY Number of Participants Who Discontinue Their Baseline 2DR Who Are Switching for Safety or Other Reasons |
1; 33; 1 | — |
| SECONDARY Number of Participants With AEs and SAEs |
1; 39; 1; 1; 2; 0 | — |
| SECONDARY Cluster of Differentiation (CD)4+ and CD8+ T Cell Counts |
411; 684; 674; 579; 712; 709 | — |
| SECONDARY CD4/CD8 Ratio |
0.60; 0.88; 0.72; 0.72; 0.89; 0.75 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04019873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.