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

Inclusion Criteria:

• Have a confirmed HIV-1 infection in the documented medical record or at screening.

• Have never received any ARTs (i.e., treatment-naïve) before screening or onlyreceived one ARV regimen (2 or 3 drugs) at least 12 weeks before screening and/orreceived any monotherapy ≤10 days in a clinical trial setting at least 12 weeksbefore screening. Participants with a documented history of PrEP and/or PEP therapybut discontinued at least 8 weeks prior to screening are also eligible forinclusion.

• Have a CD4+ cell count ≥200 cells/mm3 at screening.

Exclusion Criteria:

• Have a hepatitis B surface antigen or positive hepatitis C virus antibody atscreening. An HCV confirmation (HCV RNA test) will be performed at a centrallaboratory if the HCV antibodies screening result is positive. If the HCV RNA testresult is negative, the participant will be eligible.

• Have a positive drug screen for amphetamines, barbiturates, cocaine, opiates,benzodiazepines, heroin, or phencyclidine. However, if in the opinion of theinvestigator, positive drug screen results may be due to prescription medication fortherapeutic purposes (e.g., prescription Adderall for ADHD), eligibility decisionshall rely on the investigator's medical judgment and should be documented.

• Have a history of regular alcohol consumption, defined as an average weekly intakeof >14 drinks (males) or >7 drinks (females), within 6 months of screening and/orhas positive alcohol screen at screening and baseline.

• Have received the following treatments as PrEP or PEP (≥1 dose) prior to screening:monoclonal antibodies, HIV-1 maturation inhibitors, and long-acting INSTIs (such ascabotegravir).

• Pregnant or lactating females.

• Have a history of clinically relevant pancreatitis or hepatitis within the previous 6 months.

• Participant received any allosteric HIV-1 integrase inhibitor (ALLINI, ≥1 dose)and/or received any long-acting ARVs (marketed or investigational, ≥1 dose) prior toscreening.

• Have previously failed an INSTIs-containing regimen.