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

HIV-1-infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05869643
• Other study ID #: STP-POC-001
• Status: Recruiting
• Phase: Phase 2
• Start date: May 23, 2023
• Est. completion date: November 21, 2024

Study information

• Verified date: May 2024
• Source: ST Pharm Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: November 21, 2024
• Est. primary completion date: October 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• HIV-1-infection
• Infections

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	St Hope Foundation, Inc	Bellaire	Texas
United States	Be Well Medical Center	Berkley	Michigan
United States	North Texas Infectious Diseases Consultants, P.A.	Dallas	Texas
United States	Midway Immunology and Research Center	Fort Pierce	Florida
United States	Kaiser Permenente Los Angeles Medical Center	Los Angeles	California
United States	Ruane Clinical Research, Inc.	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
United States	Schiff Center for Liver Diseases/University of Miami	Miami	Florida
United States	Saint Michael's Medical Center	Newark	New Jersey
United States	Orlando Immunology Center	Orlando	Florida
United States	South Jersey Infectious Disease	Somers Point	New Jersey
United States	USF Health South Tampa Center for Advanced Healthcare	Tampa	Florida
United States	Atrium Health Wake Forest Baptist Medical Center - PPDS	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
ST Pharm Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Mean area under the concentration-time curve from zero to 24 hours (AUC0-24h)		Day 1, Day 10
Primary	Mean observed maximum concentration after administration (Cmax)		Day 1, Day 10
Primary	Mean time to reach Cmax (Tmax)		Day 1, Day 10
Primary	Mean observed concentration at 24 hours after administration (C24h)		Day 2, Day 4, Day 7, Day10, Day 11
Primary	Mean area under the concentration-time curve to infinite time (AUCinf)		Day 10
Primary	Mean area under the concentration-time curve to time t (AUCt)		Day 10
Primary	Mean terminal half-life (t1/2)		Day 10
Primary	Mean apparent oral clearance (CL/F)		Day 10
Primary	Mean apparent volume of distribution (Vd/F)		Day 10
Secondary	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
Secondary	HIV-1 RNA change in plasma from baseline to nadir over 11 days.		Day 1 pre-dose, Day 11
Secondary	Plasma HIV-1 RNA rate of decline over 11 days		Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
Secondary	Number of participants with HIV-1 RNA <400 copies/mL	descriptive statistics.	Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
Secondary	Number of participants with HIV-1 RNA <50 copies/mL		Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
Secondary	CD4+ cell count change		Day 1, Day 11
Secondary	STP0404 exposure-efficacy relationship in plasma HIV-1 RNA copies / CD4+ cell count		Day 1, Day 11
Secondary	Emergence of drug resistance mutations.		Screening, Day 1, Day 4, Day 7, Day 11