Aikening Adverse Reactions

Two Phase 1, one Phase 2 and one Phase 3 clinical studies of AIKENING have been completed. A total of 272 patients with HIV-1 infection have received at least one dose of AIKENING treatment. The safety assessment of AIKENING was primarily based on the randomized, controlled phase 3 clinical study (TALENT study) in treatment-experienced, HIV-1 infected patients, in which ABT group received the AIKENING and LPV/r combination therapy, and NRTI group received the standard 3-drug regimen of LPV/r + Tenofovir (TDF) or Zidovudine (AZT) + Lamivudine (3TC). In this phase 3 study, 401 subjects received at least one dose of drugs, of whom 195 received AIKENING treatment. The incidences of adverse drug reactions (ADRs) in ABT group and NRTI group showed no significant difference, and no serious adverse reactions (SARs) occurred in ABT group.
Adverse reactions: Table 3 summarizes grade 2 to 4 ADRs with incidence rates ≥2% in phase 3 study. The most common ADRs in ABT group were blood triglycerides increased and blood cholesterol increased, followed by hyperlipidaemia and hypercholesterolaemia. Abnormal blood lipid metabolism is the ADRs with the highest incidence, but since this is a combination treatment, moreover, dyslipidemia and diarrhea are common adverse reactions of LPV/r, it couldn’t be excluded the relationship to LPV/r. (See Table 3.)

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