ViiV Healthcare is beginning Phase III clinical trials of Tivicay (dolutegravir) and Edurant (rilpivirine) to treat HIV among those switching from another stable regimen. If successful, the trial could lead to the first two-drug (as opposed to the standard three- or four-drug) HIV regimen. The study will give participants the pair of antiretrovirals (ARVs) as individual tablets, although separate research is developing them as a fixed-dose combination tablet.

SWORD-1 and SWORD-2 are replicate 148-week, randomized, open-label, non-inferiority studies of the integrase inhibitor Tivicay and the non-nucleoside reverse transcriptase inhibitor (NNRTI or non-nuke) Edurant. Each study will endeavor to enroll about 500 HIV-positive participants in 13 countries, ideally with significant proportions of individuals typically underrepresented in clinical trials of ARVs, including women and people over 50 years old.

The participants will be virally suppressed at the outset, due to treatment with integrase inhibitor-, NNRTI-, or protease inhibitor-based regimens. Those in the active arm of the study will switch to Tivicay and Edurant, while those in the control group will stay on their same regimen.

The researchers will primarily look to see what proportions of the participants have a fully suppressed viral load after 48 weeks of treatment. They will also determine rates of viral resistance among the participants, and the safety and tolerability of their regimen, as well as shifts in indicators of kidney, bone and cardiovascular health. Additionally, the trial will examine participants’ willingness to switch ARV treatments, how the regimen affects health-related quality of life, and participants’ medication adherence.

To read a press release on the partnership, click here.