A Clinical Trial of STP0404 in Adults With HIV-1 Infection | NCT05869643

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Cohort 1 STP0404	Experimental	Drug: Low-dose STP0404 (Pirmitegravir)
Cohort 1	Placebo Comparator	Drug: Placebo
Cohort 2 STP0404	Experimental	Drug: Medium-dose STP0404 (Pirmitegravir)
Cohort 2	Placebo Comparator	Drug: Placebo
Cohort 3 STP0404	Experimental	Drug: High-dose STP0404 (Pirmitegravir)
Cohort 3	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Low-dose STP0404 (Pirmitegravir)	Drug	Once daily, oral capsule taken after breakfast	Cohort 1 STP0404

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HIV-1 RNA copies change in plasma	Change in plasma HIV-1 RNA log10 copies 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

Secondary Outcomes

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

Eligibility Module

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.

Facility	Status	City	State	ZIP	Country	Contacts
Kaiser Permenente Los Angeles Medical Center		Los Angeles	California	90027	United States
Ruane Clinical Research, Inc.