Clinical trial NCT05869643: A Clinical Trial of STP0404 in Adults With HIV-1 Infection
Official title: A Phase 2a, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Investigate the Antiviral Effect, Safety, Tolerability, and Pharmacokinetics of STP0404 in Adults With HIV-1 Infection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: HIV-1-infection
Lead sponsor: ST Pharm Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

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. 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.

Primary outcomes:
measure: HIV-1 RNA copies change in plasma
timeFrame: Day 1, Day 11
measure: Total Number of Adverse Events (AEs) occurring through Day 11
timeFrame: Through day 11
measure: Total Number of Serious Adverse Events (SAEs) occurring through Day 11
timeFrame: Through day 11
measure: Mean area under the concentration-time curve from zero to 24 hours (AUC0-24h)
timeFrame: Day 1, Day 10
measure: Mean observed maximum concentration after administration (Cmax)
timeFrame: Day 1, Day 10
measure: Mean time to reach Cmax (Tmax)
timeFrame: Day 1, Day 10
measure: Mean observed concentration at 24 hours after administration (C24h)
timeFrame: Day 2, Day 4, Day 7, Day10, Day 11
measure: Mean area under the concentration-time curve to infinite time (AUCinf)
timeFrame: Day 10
measure: Mean area under the concentration-time curve to time t (AUCt)
timeFrame: Day 10
measure: Mean terminal half-life (t1/2)
timeFrame: Day 10
measure: Mean apparent oral clearance (CL/F)
timeFrame: Day 10
measure: Mean apparent volume of distribution (Vd/F)
timeFrame: Day 10
Secondary outcomes:
measure: HIV-1 RNA copies change in plasma from baseline to post-dose timepoints
timeFrame: Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
measure: HIV-1 RNA change in plasma from baseline to nadir over 11 days.
timeFrame: Day 1 pre-dose, Day 11
measure: Plasma HIV-1 RNA rate of decline over 11 days
timeFrame: Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
measure: Number of participants with HIV-1 RNA <400 copies/mL
timeFrame: Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
measure: Number of participants with HIV-1 RNA <50 copies/mL
timeFrame: Day 1, Day 2, Day 4, Day 7, Day 10, Day 11
measure: CD4+ cell count change
timeFrame: Day 1, Day 11
measure: STP0404 exposure-efficacy relationship in plasma HIV-1 RNA copies / CD4+ cell count
timeFrame: Day 1, Day 11
measure: Emergence of drug resistance mutations.
timeFrame: Screening, Day 1, Day 4, Day 7, Day 11
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permenente Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: Ruane Clinical Research, Inc.
state: California
city: Fort Pierce
country: United States
facility: Midway Immunology and Research Center
state: Florida
city: Miami
country: United States
facility: Schiff Center for Liver Diseases/University of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Tampa
country: United States
facility: USF Health South Tampa Center for Advanced Healthcare
state: Florida
city: Berkley
country: United States
facility: Be Well Medical Center
state: Michigan
city: Newark
country: United States
facility: Saint Michael's Medical Center
state: New Jersey
city: Somers Point
country: United States
facility: South Jersey Infectious Disease
state: New Jersey
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Medical Center - PPDS
state: North Carolina
city: Bellaire
country: United States
facility: St Hope Foundation, Inc
state: Texas
city: Dallas
country: United States
facility: North Texas Infectious Diseases Consultants, P.A.
state: Texas
Study officials:
References: