Patients who present late on during their acquisition of the HIV-1 (Human Immunodeficiency Virus)
Conditions
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
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to failure, as the first occurrence of specified virological or clinical reasons. | — |
Secondary
| Measure | Time 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