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

NCT05869643 | Recruiting Phase 2 FDA Drug

• 1 other identifier: STP-POC-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (12)

• 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

• 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

Secondary Outcomes (8)

• 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

  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

Study Arms (6)

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

Interventions

Low-dose STP0404 (Pirmitegravir) DRUG

Once daily, oral capsule taken after breakfast

Cohort 1 STP0404

Medium-dose STP0404 (Pirmitegravir) DRUG

Once daily, oral capsule taken after breakfast

Cohort 2 STP0404

High-dose STP0404 (Pirmitegravir) DRUG

Once daily, oral capsule taken after breakfast

Cohort 3 STP0404

Placebo DRUG

Matching placebo capsule, taken orally once daily after breakfast

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a confirmed HIV-1 infection in the documented medical record or at screening.
• Have a CD4+ cell count ≥200 cells/mm3 at screening.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ST Pharm Co., Ltd.: lead

Study Sites (13)

Kaiser Permenente Los Angeles Medical Center

Los Angeles, California, 90027, United States

RECRUITING

Ruane Clinical Research, Inc.

Los Angeles, California, 90036, United States

RECRUITING

Midway Immunology and Research Center

Ft. Pierce, Florida, 34982, United States

RECRUITING

Schiff Center for Liver Diseases/University of Miami

Miami, Florida, 33136-2107, United States

COMPLETED

Orlando Immunology Center

Orlando, Florida, 32803, United States

RECRUITING

USF Health South Tampa Center for Advanced Healthcare

Tampa, Florida, 33602-3511, United States

RECRUITING

Be Well Medical Center

Berkley, Michigan, 48072, United States

RECRUITING

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

RECRUITING

South Jersey Infectious Disease

Somers Point, New Jersey, 08244, United States

RECRUITING

North Shore University Hospital

Manhasset, New York, 11030-3816, United States

RECRUITING

Atrium Health Wake Forest Baptist Medical Center - PPDS

Winston-Salem, North Carolina, 27157, United States

RECRUITING

St Hope Foundation, Inc

Bellaire, Texas, 77401, United States

RECRUITING

North Texas Infectious Diseases Consultants, P.A.

Dallas, Texas, 75246, United States

COMPLETED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Initial randomization to Cohort 1 or 2 will not be blinded. However, randomization within each cohort to either receive STP0404 or matching placebo is blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 22, 2023
• Study Start: May 23, 2023
• Primary Completion: April 10, 2026
• Study Completion: April 30, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)