VH4004280 (VH-280) vs VH4011499

NCT06039579 · Phase 2 · completed

This is a randomized, double-blind, placebo-controlled parallel-group trial, but the primary endpoint is a surrogate biomarker (plasma HIV-1 RNA) rather than a hard clinical/endoscopic outcome, and the sample size is small (only 3-7 participants per arm), which limits precision and power. Although the posted results show large antiviral effects in the active arms relative to placebo, no statistical significance testing or confidence intervals are provided, so the primary comparison cannot be confirmed as met.

NCT06039579 · Phase 2 · completed

This Phase 2 trial was randomized, double-blind (participant and investigator), and placebo-controlled, with 44 participants allocated across multiple dose groups of VH4004280 and VH4011499. The primary endpoint was the maximum change in plasma HIV-1 RNA during 10-day monotherapy; posted results for VH4011499 show mean declines of about -1.8 to -2.2 log10 in active arms versus -0.18 log10 in placebo, but no p-values or confidence intervals are reported. Because the groups are very small (6-7 active vs 3 placebo) and the statistical significance of the primary comparison is not documented, this constitutes real but limited evidence.