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

A Phase 2a, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Investigate the Antiviral Effect, Safety, Tolerability, and Pharmacokinetics of STP0404 in Treatment-Naïve Adults With HIV-1 Infection

The purpose of this study is to evaluate the antiviral effect, safety, tolerability, and pharmacokinetics of STP0404 in treatment naïve adult participants living with Human Immunodeficiency Virus Type 1 (HIV-1) infection.

Study Overview

• Status: Recruiting
• Conditions: HIV-1-infection
• Intervention / Treatment: Drug: Low-dose STP0404 (Pirmitegravir); Drug: Placebo; Drug: Medium-dose STP0404 (Pirmitegravir); Drug: High-dose STP0404 (Pirmitegravir)

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Not yet recruiting
      • Kaiser Permenente Los Angeles Medical Center
      • Contact: William Towner, MD; Phone Number: 323-783-8977; Email: William.j.towner@kp.org
    • Los Angeles, California, United States, 90036
      • Recruiting
      • Ruane Clinical Research, Inc.
      • Contact: Peter Ruane, MD; Phone Number: 1111 323-954-0400; Email: pjruane@ruaneclinicalresearch.com
  • Florida
    • Fort Pierce, Florida, United States, 34982
      • Recruiting
      • Midway Immunology and Research Center
      • Contact: Moti Ramgopal, MD; Phone Number: 772-595-9830; Email: mramgopal@midwayresearch.com
    • Miami, Florida, United States, 33136-2107
      • Not yet recruiting
      • Schiff Center for Liver Diseases/University of Miami
      • Contact: Dushyantha Jayaweera, MD; Phone Number: 786-300-6747; Email: djayawee@med.miami.edu
    • Orlando, Florida, United States, 32803
      • Not yet recruiting
      • Orlando Immunology Center
      • Contact: Edwin DeJesus, MD; Phone Number: 2107 407-647-3960; Email: edejesus@oicorlando.com
    • Tampa, Florida, United States, 33602-3511
      • Not yet recruiting
      • USF Health South Tampa Center for Advanced Healthcare
      • Contact: Casanas Beata, MD; Phone Number: 813-844-4187; Email: beata@usf.edu
  • Michigan
    • Berkley, Michigan, United States, 48072
      • Not yet recruiting
      • Be Well Medical Center
      • Contact: Paul Benson; Phone Number: 248-544-9300; Email: DRPAULBENSON@DOCTORBEWELL.com
  • New Jersey
    • Newark, New Jersey, United States, 07102
      • Recruiting
      • Saint Michael's Medical Center
      • Contact: Jihad Slim, MD; Phone Number: 973-877-5162; Email: jsmdsmmc@gmail.com
    • Somers Point, New Jersey, United States, 08244
      • Recruiting
      • South Jersey Infectious Disease
      • Contact: Christopher Lucasti; Phone Number: 609-927-6662; Email: Infect123@aol.com
  • New York
    • Manhasset, New York, United States, 11030-3816
      • Recruiting
      • North Shore University Hospital
      • Contact: Joseph McGowan, MD; Phone Number: 516-562-4280; Email: jmcgowan@northwell.edu
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Atrium Health Wake Forest Baptist Medical Center - PPDS
      • Contact: John Williamson, PharmD; Phone Number: 336-713-3431; Email: johnwill@wakehealth.edu
  • Texas
    • Bellaire, Texas, United States, 77401
      • Not yet recruiting
      • St Hope Foundation, Inc
      • Contact: James Sims III; Phone Number: 713-839-7111; Email: drsims@offeringhope.org
    • Dallas, Texas, United States, 75246
      • Recruiting
      • North Texas Infectious Diseases Consultants, P.A.
      • Contact: Mezgebe Berhe; Phone Number: 214-823-2533; Email: mezgebe.berhe@ntidc.org

Participation Criteria

Eligibility Criteria

• 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 antiretroviral therapy (ART) after diagnosis of HIV-1 infection; Participants with a history of PrEP or PEP therapy are eligible for inclusion (except for monoclonal antibodies, maturation inhibitors, and INSTIs, such as cabotegravir) if they have discontinued therapy at least 8 weeks prior to 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
• Have a history of regular alcohol consumption, defined as an average weekly intake of more than14 drinks (for males) or more than 7 drinks (for females), within 6 months of screening
• Have received the following antiretrovirals (ARVs): monoclonal antibodies, maturation inhibitors, and INSTIs (such as cabotegravir) used as PEP or PrEP
• Pregnant or lactating females
• Have a history of clinically relevant pancreatitis or hepatitis within the previous 6 months

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
HIV-1 RNA copies change in plasma	Ratio of change in plasma HIV-1 RNA 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	descriptive statistics.	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
CD4+ cell count change		Day 1, Day 11
STP0404 exposure-efficacy relationship in plasma HIV-1 RNA copies / CD4+ cell count		Day 1, Day 11
Emergence of drug resistance mutations.		Screening, Day 1, Day 4, Day 7, Day 11

Collaborators and Investigators

• Sponsor: ST Pharm Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Estimated): October 21, 2024
• Study Completion (Estimated): November 21, 2024

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Urogenital Diseases; Genital Diseases; HIV Infections; Infections; Communicable Diseases
• Other Study ID 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