HIV-1-infectionPhase 2NCT05869643
A Clinical Trial of STP0404 in Adults With HIV-1 Infection
A Phase 2 study testing Low-dose STP0404 (Pirmitegravir), Medium-dose STP0404 (Pirmitegravir) and High-dose STP0404 (Pirmitegravir) in people with HIV-1-infection, run by ST Pharm Co., Ltd. at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Low-dose STP0404 (Pirmitegravir), Medium-dose STP0404 (Pirmitegravir) and High-dose STP0404 (Pirmitegravir)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 13 sitesUnited States
- Study dates
- 23 May 2023to 6 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
St Hope Foundation, Inc
Bellaire, Texas, 77401
Be Well Medical Center
Berkley, Michigan, 48072
North Texas Infectious Diseases Consultants, P.A.
Dallas, Texas, 75246
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982
Kaiser Permenente Los Angeles Medical Center
Los Angeles, California, 90027
Ruane Clinical Research, Inc.
Los Angeles, California, 90036
North Shore University Hospital
Manhasset, New York, 11030-3816
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, 33136-2107
Saint Michael's Medical Center
Newark, New Jersey, 07102
Orlando Immunology Center
Orlando, Florida, 32803
South Jersey Infectious Disease
Somers Point, New Jersey, 08244
USF Health South Tampa Center for Advanced Healthcare
Tampa, Florida, 33602-3511
Atrium Health Wake Forest Baptist Medical Center - PPDS
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
- Conditions
- HIV-1-infection
- Being tested
- Low-dose STP0404 (Pirmitegravir), Medium-dose STP0404 (Pirmitegravir), High-dose STP0404 (Pirmitegravir), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose STP0404 (Pirmitegravir)Drug
Once daily, oral capsule taken after breakfast
Medium-dose STP0404 (Pirmitegravir)Drug
Once daily, oral capsule taken after breakfast
High-dose STP0404 (Pirmitegravir)Drug
Once daily, oral capsule taken after breakfast
PlaceboDrug
Matching placebo capsule, taken orally once daily after breakfast
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 STP0404 | Experimental | Not described Receives: Drug: Low-dose STP0404 (Pirmitegravir) |
| Cohort 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| Cohort 2 STP0404 | Experimental | Not described Receives: Drug: Medium-dose STP0404 (Pirmitegravir) |
| Cohort 2 | Placebo comparator | Not described Receives: Drug: Placebo |
| Cohort 3 STP0404 | Experimental | Not described Receives: Drug: High-dose STP0404 (Pirmitegravir) |
| Cohort 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, Day 11
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.
Measured: 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.
Measured: Through day 11
Mean area under the concentration-time curve from zero to 24 hours (AUC0-24h)
Measured: Day 1, Day 10
Mean observed maximum concentration after administration (Cmax)
Measured: Day 1, Day 10
Mean time to reach Cmax (Tmax)
Measured: Day 1, Day 10
Mean observed concentration at 24 hours after administration (C24h)
Measured: Day 2, Day 4, Day 7, Day10, Day 11
Mean area under the concentration-time curve to infinite time (AUCinf)
Measured: Day 10
Mean area under the concentration-time curve to time t (AUCt)
Measured: Day 10
Mean terminal half-life (t1/2)
Measured: Day 10
Mean apparent oral clearance (CL/F)
Measured: Day 10
Mean apparent volume of distribution (Vd/F)
Measured: Day 10
Secondary outcomes (8)
HIV-1 RNA copies change in plasma from baseline to post-dose timepoints
Measured: 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.
Measured: Day 1 pre-dose, Day 11
Plasma HIV-1 RNA rate of decline over 11 days
Measured: Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
Number of participants with HIV-1 RNA <400 copies/mL
descriptive statistics.
Measured: Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
Number of participants with HIV-1 RNA <50 copies/mL
Measured: Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
CD4+ cell count change
Measured: Day 1, Day 11
STP0404 exposure-efficacy relationship in plasma HIV-1 RNA copies / CD4+ cell count
Measured: Day 1, Day 11
Emergence of drug resistance mutations.
Measured: Screening, Day 1, Day 4, Day 7, Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start23 May 2023
- Primary completion25 Apr 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- ST Pharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869643
- Sponsor's protocol ID
- STP-POC-001
- Status last verified
- May 2026
- First submitted
- 17 Apr 2023
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05869643
- Acronym / sponsor ID
- STP-POC-001
- Conditions
- HIV-1-infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- ST Pharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 May 2023 (actual)
- Primary completion
- 25 Apr 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 STP0404 | Experimental | Drug: Low-dose STP0404 (Pirmitegravir) |
| Cohort 1 | Placebo comparator | Drug: Placebo |
| Cohort 2 STP0404 | Experimental | Drug: Medium-dose STP0404 (Pirmitegravir) |
| Cohort 2 | Placebo comparator | Drug: Placebo |
| Cohort 3 STP0404 | Experimental | Drug: High-dose STP0404 (Pirmitegravir) |
| Cohort 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose STP0404 (Pirmitegravir)Once daily, oral capsule taken after breakfast | Drug | Cohort 1 STP0404 |
| Medium-dose STP0404 (Pirmitegravir)Once daily, oral capsule taken after breakfast | Drug | Cohort 2 STP0404 |
| High-dose STP0404 (Pirmitegravir)Once daily, oral capsule taken after breakfast | Drug | Cohort 3 STP0404 |
| PlaceboMatching placebo capsule, taken orally once daily after breakfast | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
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.
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.
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.
Mean area under the concentration-time curve from zero to 24 hours (AUC0-24h)
Time frame: Day 1, Day 10
Mean observed maximum concentration after administration (Cmax)
Time frame: Day 1, Day 10
Mean time to reach Cmax (Tmax)
Time frame: Day 1, Day 10
Mean observed concentration at 24 hours after administration (C24h)
Time frame: Day 2, Day 4, Day 7, Day10, Day 11
Mean area under the concentration-time curve to infinite time (AUCinf)
Time frame: Day 10
Mean area under the concentration-time curve to time t (AUCt)
Time frame: Day 10
Mean terminal half-life (t1/2)
Time frame: Day 10
Mean apparent oral clearance (CL/F)
Time frame: Day 10
Mean apparent volume of distribution (Vd/F)
Time frame: Day 10
8 secondary outcomes
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
HIV-1 RNA change in plasma from baseline to nadir over 11 days.
Time frame: 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
Number of participants with HIV-1 RNA <400 copies/mL
Time frame: 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
CD4+ cell count change
Time frame: Day 1, Day 11
STP0404 exposure-efficacy relationship in plasma HIV-1 RNA copies / CD4+ cell count
Time frame: Day 1, Day 11
Emergence of drug resistance mutations.
Time frame: Screening, Day 1, Day 4, Day 7, Day 11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low-dose STP0404 (Pirmitegravir), Medium-dose STP0404 (Pirmitegravir) and High-dose STP0404 (Pirmitegravir) in people with HIV-1-infection, run by ST Pharm Co., Ltd. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV-1 RNA copies change in plasma (time frame: Day 1, Day 11). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.