A Clinical Trial of STP0404 in Adults With HIV-1 Infection
- Conditions
- HIV-1-infection
- Interventions
- Drug: Low-dose STP0404 (Pirmitegravir)Drug: PlaceboDrug: Medium-dose STP0404 (Pirmitegravir)Drug: High-dose STP0404 (Pirmitegravir)
- Registration Number
- NCT05869643
- Lead Sponsor
- ST Pharm Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 STP0404 Low-dose STP0404 (Pirmitegravir) - Cohort 1 Placebo - Cohort 2 STP0404 Medium-dose STP0404 (Pirmitegravir) - Cohort 2 Placebo - Cohort 3 STP0404 High-dose STP0404 (Pirmitegravir) - Cohort 3 Placebo -
- Primary Outcome Measures
Name Time Method Mean observed maximum concentration after administration (Cmax) Day 1, Day 10 Mean area under the concentration-time curve to time t (AUCt) Day 10 Total Number of Adverse Events (AEs) occurring through Day 11 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 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) Day 1, Day 10 HIV-1 RNA copies change in plasma Day 1, Day 11 Ratio of change in plasma HIV-1 RNA from baseline to Day 11 following a 10-day treatment period at each dose level.
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 terminal half-life (t1/2) Day 10 Mean apparent oral clearance (CL/F) Day 10 Mean apparent volume of distribution (Vd/F) Day 10 Mean time to reach Cmax (Tmax) Day 1, Day 10
- Secondary Outcome Measures
Name Time Method HIV-1 RNA change in plasma from baseline to nadir over 11 days. Day 1 pre-dose, Day 11 Emergence of drug resistance mutations. Screening, Day 1, Day 4, Day 7, Day 11 Number of participants with HIV-1 RNA <50 copies/mL Day 1, Day 2, Day 4, Day 7, Day 10, Day 11 STP0404 exposure-efficacy relationship in plasma HIV-1 RNA copies / CD4+ cell count Day 1, Day 11 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 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 descriptive statistics.
CD4+ cell count change Day 1, Day 11
Trial Locations
- Locations (13)
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
🇺🇸Fort 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