Dapivirine vs Rilpivirine

NCT01617096 · Phase 3 · completed

This Phase 3 trial randomized 2,629 women to a monthly dapivirine vaginal ring or a placebo ring, with both participants and investigators blinded. The primary endpoint was HIV-1 seroconversion, and the results show 71 seroconversions among 1,313 women in the dapivirine group versus 97 among 1,313 in the placebo group; however, no p-value or confidence interval is provided in the registry, so it is uncertain whether this difference was statistically significant. Because the design is robust but the primary comparison's significance is not established, the evidence is moderate rather than strong.

NCT00540449 · Phase 3 · completed

This was a large (690-participant), randomized, quadruple-blinded, active-controlled (efavirenz) phase 3 trial with a hard clinical endpoint (confirmed viral load <50 copies/mL). The pre-specified non-inferiority margin was clearly met, with the confidence interval for the treatment difference falling entirely within the allowed -12% boundary, so rilpivirine was shown to be as effective as efavirenz on the primary measure despite a somewhat higher rate of virologic failure and resistance emergence as a secondary finding.