Table 2.
Main clinical studies with dolutegravir: an overview
| Study (phase) | Patients (n) | DTG dose | Active comparator | Primary endpoint | Secondary endpoints |
|---|---|---|---|---|---|
| SPRING-I (IIb) | |||||
| Partially blinded (dose ranging) | ARV-naïve (205) | DTG 10 mg; 25 mg; 50 mg QD + TDF-FTC or ABC-3TC fixed doses | EFV 600 mg QD | VL < 50 copies/mL at week 16 | Safety Tolerability Efficacy |
| SPRING-2(III) | |||||
| Double-blind | ARV-naïve (822) | DTG 50 mg QD + 2 NRTIs | RAL 400 mg BID | VL < 50 copies/mL at week 48 | Safety Tolerability Efficacy |
| SINGLE (III) | |||||
| Double-blind | ARV-naïve (833) | DTG 50 mg + ABC-3TC QD Or TDF-FTC-EFV QD | TDF-FTC-EFV QD | VL < 50 copies/mL at week 48 | Safety Tolerability Efficacy |
| VIKING 1-2 (Mb) | |||||
| Single-arm | ARV-experienced RAL resistance Cohort 1 (27) | DTG 50 mg QD for 10 days then DTG 50 mg QD + OBT | None | VL < 400 copies/mL or ≥0.7 log10 decrease at day 11 | Efficacy (virological) |
| ARV-experienced RAL resistance Cohort 2 (24) | DTG 50 mg QD for 10 days then DTG 50 mg BID + OBT | None | VL < 400 copies/mL or ≥0.7 log10 decrease at day 11 | Efficacy (virological) Safety | |
| VIKING-3(IM) | |||||
| Single-arm | ARV-experienced RAL/EVG resistance (183) | DTG 50 mg BID + OBT | None | VL < 50 copies/mL at week 24 | Efficacy (virological) Safety |
| SAILING (III) | |||||
| Double-blind (ongoing) | ARV-experienced INI-naïve (688) | DTG 50 mg QD | RAL 400 mg BID | VL < 50 copies/mL at week 48 | Safety Tolerability Efficacy |
Abbreviations: ARV, antiretroviral therapy; OBT, optimized background therapy; QD, once daily; BID, twice daily; VL, viral load; INI, integrase inhibitor; TDF, tenofovir difumarate; ZDV, zidovudine; ABC, abacavir; 3TC, lamivudine; FTC, emtricitabine; DDI, didanosine; EFV, efavirenz; ETR, etravirine; NVP, nevirapine; DTG, dolutegravir; RAL, raltegravir; EVG, elvitegravir; NRTIs, nucleoside reverse transcriptase inhibitors.