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

May 6, 2026 updated by: ST Pharm Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Number of Adverse Events (AEs) occurring through Day 11
Time Frame: 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
Time Frame: 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)
Time Frame: Day 1, Day 10
Day 1, Day 10
Mean observed maximum concentration after administration (Cmax)
Time Frame: Day 1, Day 10
Day 1, Day 10
Mean time to reach Cmax (Tmax)
Time Frame: Day 1, Day 10
Day 1, Day 10
Mean observed concentration at 24 hours after administration (C24h)
Time Frame: Day 2, Day 4, Day 7, Day10, Day 11
Day 2, Day 4, Day 7, Day10, Day 11
Mean area under the concentration-time curve to infinite time (AUCinf)
Time Frame: Day 10
Day 10
Mean area under the concentration-time curve to time t (AUCt)
Time Frame: Day 10
Day 10
Mean terminal half-life (t1/2)
Time Frame: Day 10
Day 10
Mean apparent oral clearance (CL/F)
Time Frame: Day 10
Day 10
Mean apparent volume of distribution (Vd/F)
Time Frame: Day 10
Day 10
HIV-1 RNA copies change in plasma
Time Frame: Day 1, Day 11
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HIV-1 RNA copies change in plasma from baseline to post-dose timepoints
Time Frame: Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
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.
Time Frame: Day 1 pre-dose, Day 11
Day 1 pre-dose, Day 11
Plasma HIV-1 RNA rate of decline over 11 days
Time Frame: Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
Number of participants with HIV-1 RNA <400 copies/mL
Time Frame: Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
descriptive statistics.
Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
Number of participants with HIV-1 RNA <50 copies/mL
Time Frame: Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
CD4+ cell count change
Time Frame: Day 1, Day 11
Day 1, Day 11
STP0404 exposure-efficacy relationship in plasma HIV-1 RNA copies / CD4+ cell count
Time Frame: Day 1, Day 11
Day 1, Day 11
Emergence of drug resistance mutations.
Time Frame: Screening, Day 1, Day 4, Day 7, Day 11
Screening, Day 1, Day 4, Day 7, Day 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ST Pharm Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 6, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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