A Clinical Trial of STP0404 in Adults With HIV-1 Infection
NCT ID: NCT05869643
Last Updated: 2026-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
36 participants
INTERVENTIONAL
2023-05-23
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1 STP0404
Low-dose STP0404 (Pirmitegravir)
Once daily, oral capsule taken after breakfast
Cohort 1
Placebo
Matching placebo capsule, taken orally once daily after breakfast
Cohort 2 STP0404
Medium-dose STP0404 (Pirmitegravir)
Once daily, oral capsule taken after breakfast
Cohort 2
Placebo
Matching placebo capsule, taken orally once daily after breakfast
Cohort 3 STP0404
High-dose STP0404 (Pirmitegravir)
Once daily, oral capsule taken after breakfast
Cohort 3
Placebo
Matching placebo capsule, taken orally once daily after breakfast
Interventions
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Low-dose STP0404 (Pirmitegravir)
Once daily, oral capsule taken after breakfast
Medium-dose STP0404 (Pirmitegravir)
Once daily, oral capsule taken after breakfast
High-dose STP0404 (Pirmitegravir)
Once daily, oral capsule taken after breakfast
Placebo
Matching placebo capsule, taken orally once daily after breakfast
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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ST Pharm Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Kaiser Permenente Los Angeles Medical Center
Los Angeles, California, United States
Ruane Clinical Research, Inc.
Los Angeles, California, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
USF Health South Tampa Center for Advanced Healthcare
Tampa, Florida, United States
Be Well Medical Center
Berkley, Michigan, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
South Jersey Infectious Disease
Somers Point, New Jersey, United States
North Shore University Hospital
Manhasset, New York, United States
Atrium Health Wake Forest Baptist Medical Center - PPDS
Winston-Salem, North Carolina, United States
St Hope Foundation, Inc
Bellaire, Texas, United States
North Texas Infectious Diseases Consultants, P.A.
Dallas, Texas, United States
Countries
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Facility Contacts
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Other Identifiers
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STP-POC-001
Identifier Type: -
Identifier Source: org_study_id
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