Clinical Research Directory

Inclusion Criteria: * Pediatric participant with HIV-1 \<18 years of age * Body weight ≥35 kg * Is TN (HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL) or VS (HIV-1 positive at screening with plasma HIV-1 RNA \<50 copies/mL AND has received stable, continuous 2- or 3-drug antiretroviral therapy (ART) for ≥3 months prior to providing informed consent) Exclusion Criteria: * HIV-2 infection * Hypsensitivity/contraindication to any components of study medication or as determined by the investigator * Has an active diagnosis of hepatitis due to any cause * history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma * Has a history or current evidence of any condition (including active tuberculosis infection, COVID-19, or other infections), therapy, laboratory abnormality, or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study * Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies