A Phase 2b Study Evaluating VH4011499 Capsid Inhibitor Long-Acting Injectable Plus Cabotegravir in Treatment Naïve Adults (CINERGY)

Number of participants with plasma HIV-1 RNA <50 copies/mL as per FDA snapshot algorithm

Time frame: At Month 13 and Month 25

Number of participants with plasma HIV-1 RNA <50 copies/mL as per observed data

Time frame: At Month 7, Month 13 and Month 25

Change from baseline (Day 1) in cluster of differentiation (CD) 4+ T-cell count

Time frame: At Month 7, Month 13 and Month 25

Number of participants with injection site reaction adverse events of special interest (ISR AESIs) by grade

The ISR AESIs will be graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table Version 2.1, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening.

Time frame: Through Month 7, Month 13 and Month 25

Duration of ISR AESIs by grade

The ISR AESIs will be graded using the DAIDS grading table Version 2.1, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening.

Time frame: Through Month 7, Month 13 and Month 25

Number of participants with serious adverse events (SAEs) by grade

An SAE is defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, caused a congenital anomaly/birth defect, or was any other situation identified according to medical or scientific judgment. The SAEs will be graded using the DAIDS grading table Version 2.1, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.