A Clinical Trial of STP0404 in Treatment-Naïve Adults With HIV-1 Infection
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
| Placebo Comparator: Cohort 2
|
Drug: Placebo
Matching placebo capsule, taken orally once daily 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
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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]
- 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
- 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]
descriptive statistics.
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have a confirmed HIV-1 infection in the documented medical record
-
Have never received antiretroviral therapy (ART) after diagnosis of HIV-1 infection; Participants with a history of PrEP or PEP therapy (except for monoclonal antibodies and INSTI, such as cabotegravir) are eligible 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
-
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 prior treatment with any antiretroviral (ARV) including PEP or PrEP INSTI, and/or maturation inhibitor (1 or more doses).
-
Pregnant or lactating females
-
Have a history of clinically relevant pancreatitis or hepatitis within the previous 6 months
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- ST Pharm Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STP-POC-001