HIV Infections
Conditions
Brief summary
Maximum change from baseline (Day 1) in plasma HIV-1 ribonucleic acid through Day 11.
Detailed description
• Incidence of adverse events (AEs), severity of AEs and AEs leading to study treatment discontinuation • Change from baseline and maximum toxicity grade increase from baseline for liver panel laboratory parameters, PK measures that include but are not limited to: • Maximum observed plasma drug concentration (Cmax), • Time to maximum observed plasma drug concentration (tmax), • Concentrations on Day 11 for VH4004280 and VH4011499, VH4004280 and VH4011499 PK parameters with maximum change in plasma HIV-1 RNA from baseline through Day 11
Interventions
DRUGTablets are oval
DRUGbiconvex
DRUGPlacebo for GSK4011499 Tablets are tablets for oral administration. Tablets are oval
DRUGplain
DRUGand white to off white.
Sponsors
Viiv Healthcare UK Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum change from baseline (Day 1) in plasma HIV-1 ribonucleic acid through Day 11. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Incidence of adverse events (AEs), severity of AEs and AEs leading to study treatment discontinuation • Change from baseline and maximum toxicity grade increase from baseline for liver panel laboratory parameters, PK measures that include but are not limited to: • Maximum observed plasma drug concentration (Cmax), • Time to maximum observed plasma drug concentration (tmax), • Concentrations on Day 11 for VH4004280 and VH4011499, VH4004280 and VH4011499 PK parameters with maximum change in plasma HIV-1 RNA from baseline through Day 11 | — |
Countries
France, Germany, Italy, Spain
Outcome results
None listed