Trial Registered

Jiangsu Aidea tests oral ACC017 against dolutegravir as first-line HIV therapy

The Phase 1/2 trial pits a new oral antiretroviral against a standard integrase inhibitor in treatment-naive adults, in a field already crowded with small-molecule options.

Jiangsu Aidea Pharmaceutical Group registered a Phase 1/2 trial testing oral ACC017 tablets head-to-head against dolutegravir sodium tablets in treatment-naive adults with HIV-1.

By AppliedXLJuly 17, 2026Trial NCT07711223

Executive Summary

Jiangsu Aidea has registered a Phase 1/2 trial comparing its oral antiretroviral ACC017 against dolutegravir, a standard first-line HIV therapy, in adults who have never received antiretroviral treatment.
The randomized, double-blind, active-controlled design is built to show non-inferiority on viral suppression, the same bar any new first-line entrant must clear against an established comparator.
ACC017 enters a small-molecule antiretroviral landscape already populated by approved options from Gilead Sciences, ViiV Healthcare, and Merck, where the open question is differentiation rather than unmet need.
The sponsor is running a second ACC017 trial concurrently in treatment-experienced patients with resistance mutations, indicating a bridging strategy from first-line to salvage therapy.

The registration

Jiangsu Aidea Pharmaceutical Group Co., Ltd. registered NCT07711223, a Phase 1/2 trial evaluating ACC017 tablets against dolutegravir sodium tablets in treatment-naive adults with HIV-1 infection. The study is recruiting in China, targets 660 participants, and carries a primary completion date of August 31, 2028. It uses a multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group, non-inferiority design across a 48-week double-blind period followed by a 48-week open-label phase. NCT07711223+1

The endpoint bar

The primary endpoint measures the percentage of participants with HIV RNA below 50 copies per mL at 48 weeks, analyzed using the FDA Snapshot Approach, a standard virologic-suppression measure for antiretroviral approval trials. Secondary endpoints track CD4+ cell count changes through week 96, viral load reductions as early as week 4, and resistance mutation development, giving the trial a durability and safety tail well beyond the primary readout. NCT07711223

The competitive field

Small molecules dominate HIV-1 treatment, with 720 trials on record using this modality in the indication. ACC017's nearest comparators by modality are all approved, commercial-stage integrase inhibitors and reverse transcriptase inhibitors: Gilead Sciences' bictegravir and GS-1720, ViiV Healthcare's cabotegravir and dolutegravir, and Merck's islatravir and doravirine are all in Phase 2 or later testing in the same indication. Lamivudine and zidovudine, abacavir, rilpivirine, bictegravir/emtricitabine/tenofovir alafenamide, darunavir, emtricitabine/tenofovir alafenamide, tenofovir disoproxil fumarate, and raltegravir are all approved first-line or combination options for HIV-1 infection. ACC017's target and mechanism class are not established in available records, so the competitive read rests on modality and design rather than a mechanism comparison.

The bar this trial must clear

With multiple approved, durable-suppression regimens already available for treatment-naive HIV-1 patients, a new oral entrant does not need to demonstrate an unmet-need breakthrough. It needs to show non-inferiority to dolutegravir on the week-48 viral suppression endpoint, the accepted registrational bar in this indication, while holding up on the CD4+ and resistance-mutation secondary measures that will determine whether the profile supports broader positioning. NCT07711223

The sponsor's strategy

Jiangsu Aidea is running a second ACC017 trial, NCT07711210, in treatment-experienced adults with non-nucleoside reverse transcriptase inhibitor resistance mutations, enrolling 12 participants with a primary completion date of June 30, 2027. Running the treatment-naive comparator trial alongside a salvage-population study suggests the sponsor is testing ACC017 across the treatment continuum rather than in a single line of therapy. NCT07711223

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.