A Clinical Trial of STP0404 in Treatment-Naïve Adults With HIV-1 Infection

Inclusion Criteria: Have a confirmed HIV-1 infection in the documented medical record or at screening Have never received antiretroviral therapy (ART) after diagnosis of HIV-1 infection; Participants with a history of PrEP or PEP therapy are eligible for inclusion (except for monoclonal antibodies, maturation inhibitors, and INSTIs, such as cabotegravir) if they have discontinued therapy at least 8 weeks prior to screening Exclusion Criteria: Have a hepatitis B surface antigen or positive hepatitis C virus antibody at screening. An HCV confirmation (HCV RNA test) will be performed at a central laboratory if the HCV antibodies screening result is positive. If the HCV RNA test result is negative, the participant will be eligible. Have a positive drug screen for amphetamines, barbiturates, cocaine, opiates, benzodiazepines, heroin, or phencyclidine Have a history of regular alcohol consumption, defined as an average weekly intake of more than14 drinks (for males) or more than 7 drinks (for females), within 6 months of screening Have received the following antiretrovirals (ARVs): monoclonal antibodies, maturation inhibitors, and INSTIs (such as cabotegravir) used as PEP or PrEP Pregnant or lactating females Have a history of clinically relevant pancreatitis or hepatitis within the previous 6 months