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

NCT05869643 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-05-08

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • ST Pharm Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-23
Primary Completion
2026-04-25
Completion
2026-05-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05869643 on ClinicalTrials.gov