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

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.

Study Overview

• Status: Completed
• Conditions: HIV-1-infection
• Intervention / Treatment: Drug: Low-dose STP0404 (Pirmitegravir); Drug: Placebo; Drug: Medium-dose STP0404 (Pirmitegravir); Drug: High-dose STP0404 (Pirmitegravir)

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Kaiser Permenente Los Angeles Medical Center
    • Los Angeles, California, United States, 90036
      • Ruane Clinical Research, Inc.
  • Florida
    • Ft. Pierce, Florida, United States, 34982
      • Midway Immunology and Research Center
    • Miami, Florida, United States, 33136-2107
      • Schiff Center for Liver Diseases/University of Miami
    • Orlando, Florida, United States, 32803
      • Orlando Immunology Center
    • Tampa, Florida, United States, 33602-3511
      • USF Health South Tampa Center for Advanced Healthcare
  • Michigan
    • Berkley, Michigan, United States, 48072
      • Be Well Medical Center
  • New Jersey
    • Newark, New Jersey, United States, 07102
      • Saint Michael's Medical Center
    • Somers Point, New Jersey, United States, 08244
      • South Jersey Infectious Disease
  • New York
    • Manhasset, New York, United States, 11030-3816
      • North Shore University Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist Medical Center - PPDS
  • Texas
    • Bellaire, Texas, United States, 77401
      • St Hope Foundation, Inc
    • Dallas, Texas, United States, 75246
      • North Texas Infectious Diseases Consultants, P.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 only received one ARV regimen (2 or 3 drugs) at least 12 weeks before screening and/or received any monotherapy ≤10 days in a clinical trial setting at least 12 weeks before screening. Participants with a documented history of PrEP and/or PEP therapy but discontinued at least 8 weeks prior to screening are also eligible for inclusion.
• Have a CD4+ cell count ≥200 cells/mm3 at 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. However, if in the opinion of the investigator, positive drug screen results may be due to prescription medication for therapeutic purposes (e.g., prescription Adderall for ADHD), eligibility decision shall rely on the investigator's medical judgment and should be documented.
• Have a history of regular alcohol consumption, defined as an average weekly intake of >14 drinks (males) or >7 drinks (females), within 6 months of screening and/or has 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 as cabotegravir).
• 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 to screening.
• Have previously failed an INSTIs-containing regimen.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Cohort 2	Drug: Placebo; Matching placebo capsule, taken orally once daily after breakfast
Experimental: Cohort 1 STP0404	Drug: Low-dose STP0404 (Pirmitegravir); Once daily, oral capsule taken after breakfast
Placebo Comparator: Cohort 1	Drug: Placebo; Matching placebo capsule, taken orally once daily after breakfast
Experimental: Cohort 2 STP0404	Drug: Medium-dose STP0404 (Pirmitegravir); Once daily, oral capsule taken after breakfast
Experimental: Cohort 3 STP0404	Drug: High-dose STP0404 (Pirmitegravir); Once daily, oral capsule taken after breakfast
Placebo Comparator: Cohort 3	Drug: Placebo; Matching placebo capsule, taken orally once daily after breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Adverse Events (AEs) occurring through Day 11	Cumulative number of AEs occurring from Day 1 through Day 11 at each dose level and placebo in treatment-naïve adults with HIV-1 infection, regardless of treatment discontinuation, and use of prohibited medications. The severity of the AE will be rated as per the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1, July 2017. These will be descriptively summarized.	Through day 11
Total Number of Serious Adverse Events (SAEs) occurring through Day 11	Cumulative number of SAEs occurring from Day 1 through Day 11 at each dose level and placebo in treatment-naïve adults with HIV-1 infection, regardless of treatment discontinuation, use of prohibited medications, and death are included in the endpoint. These will be descriptively summarized.	Through day 11
Mean area under the concentration-time curve from zero to 24 hours (AUC0-24h)		Day 1, Day 10
Mean observed maximum concentration after administration (Cmax)		Day 1, Day 10
Mean time to reach Cmax (Tmax)		Day 1, Day 10
Mean observed concentration at 24 hours after administration (C24h)		Day 2, Day 4, Day 7, Day10, Day 11
Mean area under the concentration-time curve to infinite time (AUCinf)		Day 10
Mean area under the concentration-time curve to time t (AUCt)		Day 10
Mean terminal half-life (t1/2)		Day 10
Mean apparent oral clearance (CL/F)		Day 10
Mean apparent volume of distribution (Vd/F)		Day 10
HIV-1 RNA copies change in plasma	Change in plasma HIV-1 RNA log10 copies from baseline to Day 11 following a 10-day treatment period at each dose level.	Day 1, Day 11

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV-1 RNA copies change in plasma from baseline to post-dose timepoints		Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
HIV-1 RNA change in plasma from baseline to nadir over 11 days.		Day 1 pre-dose, Day 11
Plasma HIV-1 RNA rate of decline over 11 days		Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
Number of participants with HIV-1 RNA <400 copies/mL	descriptive statistics.	Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
Number of participants with HIV-1 RNA <50 copies/mL		Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
CD4+ cell count change		Day 1, Day 11
STP0404 exposure-efficacy relationship in plasma HIV-1 RNA copies / CD4+ cell count		Day 1, Day 11
Emergence of drug resistance mutations.		Screening, Day 1, Day 4, Day 7, Day 11

Collaborators and Investigators

• Sponsor: ST Pharm Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Actual): April 25, 2026
• Study Completion (Actual): May 6, 2026

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Immune System Diseases; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections; Infections; Communicable Diseases
• Other Study ID Numbers: STP-POC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No