NCT05869643

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: ST Pharm Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Low-dose STP0404 (Pirmitegravir)	Once daily, oral capsule taken after breakfast
DRUG	Medium-dose STP0404 (Pirmitegravir)	Once daily, oral capsule taken after breakfast
DRUG	High-dose STP0404 (Pirmitegravir)	Once daily, oral capsule taken after breakfast
DRUG	Placebo	Matching placebo capsule, taken orally once daily after breakfast

Timeline

• Start date: 2023-05-23
• Primary completion: 2026-04-10
• Completion: 2026-04-30
• First posted: 2023-05-22
• Last updated: 2026-03-11

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study