N/A
Completed N=200
Dolutegravir/Rilpivirine, Antiretroviral Efficacy Study Using Real-world Data in Subjects With Human Immunodeficiency Virus (HIV)-1
Source: ClinicalTrials.gov NCT03518060 ↗Enrolled (actual)
200
Serious AEs
26.0%
Results posted
Oct 2024
Primary outcomePrimary: Number of Participants With Sustained Virologic Suppression at Year 3 — 119; 2; 1; 1 Participants
Summary
This was a prospective, non-interventional, single-arm, multi-center study aimed at gathering real-world data on JULUCA use in routine clinical care in Germany, to supplement clinical trial data to further improve/optimize care in HIV positive participants in Germany. Approximately 250 virologically suppressed HIV positive participants on stable antiretroviral therapy (ART) were included in the study at the discretion of treating physician. Eligible participants were followed up for approximately 3 years and data was collected during routine clinical care.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Sustained Virologic Suppression at Year 3 |
119; 2; 1; 1; 23; 1 | — |
| SECONDARY Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2 |
164; 2; 0; 1; 0; 19 | — |
| SECONDARY Number of Participants With Low Level Viremia |
0; 0; 1 | — |
| SECONDARY Number of Participants With Virologic Rebound |
0; 1; 0 | — |
| SECONDARY Number of Participants With Treatment Switch |
19; 22; 23 | — |
| SECONDARY Number of Monitoring Measures During the 3-year Follow-up |
4 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
52 | — |
| SECONDARY Number of Participants With Adverse Drug Reactions (ADRs) |
41 | — |
| SECONDARY Number of Participants With Adherence to Therapy |
111; 109; 87 | — |
| SECONDARY Change From Baseline (BL) in Lipid Laboratory Values |
-2.5; 1; -0.8; -1.4; -3; 7 | — |
| SECONDARY Change in Treatment Satisfaction |
1; 2.5; 3 | — |
| SECONDARY Change in Symptom Distress |
0; -1; -1.5 | — |
| SECONDARY Number of Participants by Reasons for Therapy Switch to JULUCA |
53; 8; 41; 9; 1; 45 | — |
Eligibility Criteria
Inclusion Criteria
- Greated than or equal to (>=)18 years of age.
- Documented HIV-1 infection.
- Virologically suppressed (HIV-1 ribonucleic acid [RNA] less than [ ) 50 c/mL at any time point within 6 months prior to inclusion into this study.
- History of treatment failure.
- Known or suspected substitutions associated with resistance to any non-nucleoside reverse-transcriptase inhibitors (NNRTI) or integrase strand transfer inhibitor (INSTI).
- Any ART for the treatment of HIV-1 in addition to JULUCA.
- Hepatitis B virus (HBV)-co-infection.
- Current participation in the ongoing non-interventional study TRIUMPH (study number: 202033) or any interventional clinical trial irrespective of indication.
- Previous participation in clinical trials involving JULUCA.
Data sourced from ClinicalTrials.gov (NCT03518060). 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. Informational only — not medical advice.