Overview
The purpose of this study is to evaluate the antiviral effect, safety, tolerability, and pharmacokinetics of STP0404 in treatment naïve adult participants living with Human Immunodeficiency Virus Type 1 (HIV-1) infection.
Eligibility
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