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

• Status: Not yet recruiting
• Trial end date: 2024-05-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ST Pharm Co., Ltd.

Criteria

Inclusion Criteria:

• Have a confirmed HIV-1 infection in the documented medical record

• Have never received antiretroviral therapy (ART) after diagnosis of HIV-1 infection; Participants with a history of PrEP or PEP therapy (except for monoclonal antibodies and INSTI, such as cabotegravir) are eligible 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

• 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 prior treatment with any antiretroviral (ARV) including PEP or PrEP INSTI, and/or maturation inhibitor (1 or more doses).

• Pregnant or lactating females

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