Jiangsu Aidea tests ACC017 in HIV patients already resistant to NNRTIs
A 12-patient Phase 1/2 trial in China will show whether ACC017 can suppress HIV-1 in treatment-experienced adults whose virus already carries NNRTI resistance mutations.
Executive Summary
- Jiangsu Aidea Pharmaceutical Group has started a Phase 1/2 trial of an ACC017-based oral regimen in HIV-1 patients who have already developed resistance to their current non-nucleoside reverse transcriptase inhibitor therapy.
- The design enrolls a narrowly defined resistance population, requiring both documented NNRTI resistance and at least one drug in the nucleoside backbone that still works, rather than a general treatment-experienced group.
- ACC017 enters a reverse transcriptase inhibitor class that already includes several clinical-stage and marketed oral agents, so its differentiation rests on performance in resistant patients rather than a novel mechanism.
- Jiangsu Aidea is running a second, larger ACC017 trial against dolutegravir in treatment-naive patients, suggesting this resistance-focused cohort is one piece of a broader development plan rather than a standalone program.
The trial
The trial, registered as NCT07711210, is testing ACC017 in adults with HIV-1 who have received at least six months of a first-line regimen combining one NNRTI with two NRTIs (nucleoside reverse transcriptase inhibitors) but have developed documented resistance to the NNRTI component. The study enrolled 12 patients and is now active but not recruiting, with a primary completion date of June 30, 2027, and a broader study completion date of December 30, 2027. It runs across sites in China and randomizes patients across two arms under double-blind masking. NCT07711210Efficacy and Safety of the ACC017-Based Antiretroviral Regimen in Treatment-Experienced Adults With HIV-1 Harboring Non-Nucleoside Reverse Transcriptase Inhibitor Resistance MutationsNCT07711210
What the trial measures
The registered primary endpoint is the percentage of participants achieving HIV-1 RNA below 50 copies per milliliter, the standard viral suppression threshold, after 16 weeks of treatment. Secondary measures track adverse events, ECG and vital-sign abnormalities, laboratory findings, and CD4+ T-cell count changes, along with the trough blood concentration of ACC017. Other endpoints track genotypic resistance evolution in patients who experience virologic breakthrough, a specific concern in a population already carrying resistance mutations. NCT07711210Efficacy and Safety of the ACC017-Based Antiretroviral Regimen in Treatment-Experienced Adults With HIV-1 Harboring Non-Nucleoside Reverse Transcriptase Inhibitor Resistance MutationsNCT07711210
The eligibility bar
Enrollment criteria require confirmed NNRTI resistance mutations within eight weeks of screening, interpreted against the Stanford HIVdb resistance database, and require that at least one NRTI backbone drug remain fully active for background therapy. Patients with documented resistance to integrase strand transfer inhibitors are excluded, narrowing the population to those whose remaining options are specifically NNRTI-class failures. NCT07711210Efficacy and Safety of the ACC017-Based Antiretroviral Regimen in Treatment-Experienced Adults With HIV-1 Harboring Non-Nucleoside Reverse Transcriptase Inhibitor Resistance MutationsNCT07711210
The competitive field
Reverse transcriptase inhibitors are a mature class in HIV-1: direct comparators sharing the same target and mechanism include Bristol-Myers Squibb's atazanavir, ViiV Healthcare's fosdevirine, and Merck Sharp & Dohme's ulonivirine and MK-8583, all tested in HIV-1 populations. Ulonivirine, MK-8583, and Merck's islatravir represent the most active recent entrants, with islatravir now in a Phase 3 trial against a percentage of participants with plasma HIV-RNA above 50 copies/mL as its own primary measure. Across the reverse transcriptase-by-HIV-1 pairing, 15 trials from 10 sponsors have reached as far as Phase 4, and Phase 1 programs in this pairing have failed at a rate of 1 in 4.
The sponsor's broader program
Jiangsu Aidea is running a second ACC017 trial, NCT07711223, comparing ACC017 tablets against dolutegravir sodium tablets in treatment-naive adults with HIV-1, enrolling 660 patients with a primary completion date of August 31, 2028. That companion trial targets a treatment-naive population against an established integrase inhibitor, while this trial targets treatment-experienced patients who have already failed an NNRTI, giving the sponsor two distinct read-outs on the same molecule in different clinical settings.
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.