HIV-1 infection
Conditions
Brief summary
Proportion of participants experiencing treatment-emergent Grade 3 or 4 study drug-related adverse events (AEs) through Week 12, Proportion of participants experiencing treatment-emergent Grade 3 or 4 laboratory abnormalities through Week 12
Detailed description
Plasma concentrations of BIC, CAB and RPV at Day 1, Week 4, 12, and 24, as appropriate, Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Weeks 12 and 24 (missing = excluded and discontinuation = failure), Number and proportion of participants with B/F/TAF discontinuation by Weeks 12 and 24, Proportion of participants experiencing treatment-emergent grade 3 or 4 laboratory abnormalities through Week 24, Change in HIV treatment satisfaction (HIVTSQc) score at Week 4
Interventions
Sponsors
Gilead Sciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants experiencing treatment-emergent Grade 3 or 4 study drug-related adverse events (AEs) through Week 12, Proportion of participants experiencing treatment-emergent Grade 3 or 4 laboratory abnormalities through Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations of BIC, CAB and RPV at Day 1, Week 4, 12, and 24, as appropriate, Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Weeks 12 and 24 (missing = excluded and discontinuation = failure), Number and proportion of participants with B/F/TAF discontinuation by Weeks 12 and 24, Proportion of participants experiencing treatment-emergent grade 3 or 4 laboratory abnormalities through Week 24, Change in HIV treatment satisfaction (HIVTSQc) score at Week 4 | — |
Countries
France
Outcome results
None listed