Table 1 Summary of study characteristics of the ATLAS, FLAIR, and ATLAS-2M trials
Trial acronym (Author year) | Study design | Countries/region | Participant eligibility criteria | Intervention/comparator | Endpoints |
|---|---|---|---|---|---|
ATLAS (Swindells 2020) [13] | Randomized, multicenter, parallel-group, open-label, Phase 3 | Argentina Australia Canada Europe Mexico Republic of Korea Russian Federation South Africa USA | • On initial or second ARV regimen ≥ 6 months prior to screening • Prior switch only for tolerability/safety, access to medications, or convenience/ simplification, and NOT due to treatment failure • HIV-1 RNA < 50 copies/mL at screening and ≥ 2 HIV-1 RNA measurements < 50 copies/mL in the 12 months prior to screening | • CAB + RPV Q4W • Continued cART SoC therapy | • Primary: % participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 • Key secondary: participants with HIV-1 RNA < 50 copies/mL at Week 48 |
FLAIR (Orkin 2020) [12] | Randomized, multicenter, open-label, non-inferiority, Phase 3 | Canada Europe Japan Russian Federation South Africa USA | • Treatment naïve at screening • 20 weeks induction period with DTG/ABC/3TC • HIV-1 RNA < 50 copies/mL prior to randomization | • CAB + RPV Q4W • DTG + ABC + 3TC | • Primary: % participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 • Key secondary: participants with HIV-1 RNA < 50 copies/mL at Week 48 |
ATLAS-2M | Randomized, multicenter, parallel-group, open-label, non-inferiority, Phase 3 | Argentina Australia Canada Europe Mexico North America Republic of Korea Russian Federation South Africa USA | • Uninterrupted SoC regimen ≥ 6 months • 2 documented HIV-1 RNA viral load measurements • < 50 copies/mL in each past 2, 6-month periods and at study entry | • CAB + RPV Q4Wa • CAB + RPV Q8Wa | • Primary: % participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 • Key secondary: participants with HIV-1 RNA < 50 copies/mL at Week 48 |