A Phase 2a, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Investigate the Antiviral Effect, Safety, Tolerability, and Pharmacokinetics of STP0404 in Treatment-Naïve Adults With HIV-1 Infection

STP-POC-001

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.

2023-05-23

2024-10-21

2024-11-21

Recruiting

Early phase I

36

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Initial randomization to Cohort 1 or 2 will not be blinded. However, randomization within each cohort to either receive STP0404 or matching placebo is blinded.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}

2024-05-09