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New HIV pill STP0404 shows promise in small trial

NCT ID NCT05869643

Disease control Sponsor: ST Pharm Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2a trial tested a new experimental drug called STP0404 (Pirmitegravir) in 25 adults with HIV-1 who had never taken HIV medications before. Participants received either a low, medium, or high dose of STP0404 or a placebo once daily for 10 days. The study measured how well the drug lowered the amount of virus in the blood and checked for any side effects. The goal is to see if STP0404 can be a safe and effective new option for controlling HIV.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
STP0404 (Pirmitegravir)
What this could lead to
If successful, this could lead to a new daily pill to control HIV-1, offering another treatment option for people living with HIV.
What could go wrong
This is a small, early-phase trial (25 people) testing short-term effects over 10 days. It may not show strong enough antiviral activity or could have side effects. Larger studies are needed to confirm safety and effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

25 people

The number who actually took part.

Started

May 2023

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV-1-infection

Contacts and locations

Locations

  • Atrium Health Wake Forest Baptist Medical Center - PPDS

    Winston-Salem, North Carolina, 27157, United States

  • Be Well Medical Center

    Berkley, Michigan, 48072, United States

  • Kaiser Permenente Los Angeles Medical Center

    Los Angeles, California, 90027, United States

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982, United States

  • North Shore University Hospital

    Manhasset, New York, 11030-3816, United States

  • North Texas Infectious Diseases Consultants, P.A.

    Dallas, Texas, 75246, United States

  • Orlando Immunology Center

    Orlando, Florida, 32803, United States

  • Ruane Clinical Research, Inc.

    Los Angeles, California, 90036, United States

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102, United States

  • Schiff Center for Liver Diseases/University of Miami

    Miami, Florida, 33136-2107, United States

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244, United States

  • St Hope Foundation, Inc

    Bellaire, Texas, 77401, United States

  • USF Health South Tampa Center for Advanced Healthcare

    Tampa, Florida, 33602-3511, United States

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