Skip to content

An Open-Label, Multi-Centre, Randomised Study to Investigate Integrase Inhibitor Versus Boosted Protease Inhibitor Antiretroviral Therapy for Patients with Advanced HIV Disease -The Late Presenter Treatment Optimisation Study (LAPTOP)-

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505167-36-00
Acronym
NEAT44
Enrollment
357
Registered
2023-11-02
Start date
2019-08-05
Completion date
2024-06-17
Last updated
2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who present late on during their acquisition of the HIV-1 (Human Immunodeficiency Virus)

Brief summary

Time to failure, as the first occurrence of specified virological or clinical reasons.

Detailed description

Proportion of patients with HIV-RNA viral load < 50 copies/mL at week 24, 36, 48, HIV-1 drug resistance at confirmed virological failure (genotype), Time to reach CD4 count > 200/μL (first measurement), Proportion of patients with CD4 cell count < 200 μL and < 350μL at week 4, 8, 12, 24, 36, 48, CD4/CD8 ratio at week 4, 8, 12, 24, 36, 48, Incidence of IRIS in the two arms through week 48, Incidence and duration of hospitalisation, rate of relapse of specific OI/BI through week 48, Safety and tolerability, measured by Grade 2, 3 and 4 signs and symptoms and laboratory toxicities through week 48, ART and OI/BI treatment changes and dose modifications due to toxicities and DDI with ART, and IRIS through week 48, Health care resource use, including total inpatient days and emergency room visits through week 48, QOL and functional status outcomes, including overall self-reported QOL and functional status compared in the two groups at week 48, Discontinuation or modification of study medication due to insufficient virological response, resistance mutations at baseline, or resistance mutation development before week 48

Interventions

DRUGSymtuza 800 mg/150 mg/200 mg/10 mg film-coated tablets

Sponsors

NEAT ID Foundation
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to failure, as the first occurrence of specified virological or clinical reasons.

Secondary

MeasureTime frame
Proportion of patients with HIV-RNA viral load < 50 copies/mL at week 24, 36, 48, HIV-1 drug resistance at confirmed virological failure (genotype), Time to reach CD4 count > 200/μL (first measurement), Proportion of patients with CD4 cell count < 200 μL and < 350μL at week 4, 8, 12, 24, 36, 48, CD4/CD8 ratio at week 4, 8, 12, 24, 36, 48, Incidence of IRIS in the two arms through week 48, Incidence and duration of hospitalisation, rate of relapse of specific OI/BI through week 48, Safety and tolerability, measured by Grade 2, 3 and 4 signs and symptoms and laboratory toxicities through week 48, ART and OI/BI treatment changes and dose modifications due to toxicities and DDI with ART, and IRIS through week 48, Health care resource use, including total inpatient days and emergency room visits through week 48, QOL and functional status outcomes, including overall self-reported QOL and functional status compared in the two groups at week 48, Discontinuation or modification of study medicat

Countries

Belgium, France, Germany, Ireland, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026