Single Trial HIV: A Landmark Study in Modern HIV Treatment

The Single Trial is an important Phase 3 clinical study investigating the safety and efficacy of a once-daily antiretroviral treatment regimen for people living with HIV-1 who have never received antiretroviral therapy before. This trial compared dolutegravir combined with abacavir/lamivudine against the then-standard efavirenz/tenofovir/emtricitabine regimen.

Overview of the Single Trial

The Single Trial enrolled 833 treatment-naive HIV-1 positive participants. It was a randomized, double-blind, non-inferiority study designed to assess whether the dolutegravir-based regimen could provide viral suppression at least as well as the established standard of care.

Participants were adults with plasma HIV RNA levels above 1000 copies/mL and without certain resistance mutations. The trial followed patients for up to 144 weeks, with primary results reported at Week 48 and extended follow-up thereafter.

Key Results and Impact

• At Week 144, 71% of patients receiving dolutegravir plus abacavir/lamivudine maintained viral loads below 50 copies/mL versus 63% in the efavirenz/tenofovir/emtricitabine arm, showing statistically superior efficacy.
• The dolutegravir arm had fewer discontinuations due to adverse events (3% vs. 11% in the comparator group), indicating better tolerability.
• No treatment-emergent resistance to dolutegravir or the nucleoside backbone was observed through Week 144.
• Patient-reported outcomes showed comparable quality of life and symptom distress measures between groups.

Why the Single Trial Matters

The Single Trial was pivotal for bringing dolutegravir plus abacavir/lamivudine forward as a once-daily, single-pill option with high efficacy and safety for treatment-naive HIV-1 patients. Its results helped establish dolutegravir-based regimens as a preferred first-line therapy in many treatment guidelines worldwide.

By balancing superior viral suppression with fewer side effects and a convenient dosing schedule, the Single Trial facilitated improved adherence and long-term clinical outcomes for people living with HIV.

Conclusion

The Single Trial embodies a significant advancement in HIV treatment by demonstrating a safer, more tolerable, and highly effective once-daily regimen for people newly starting HIV therapy. This milestone continues to influence clinical practice and provides hope for improved lives through optimized HIV care.

References include clinical publications detailing the Single Trial study design, outcomes, and impact.