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NCT05869643 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial of STP0404 in Adults With HIV-1 Infection
A Phase 2 study of HIV-1-infection, sponsored by ST Pharm Co..
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 13
- Study locations
NCT05869643: Recruiting Phase 2 study of HIV-1-infection, sponsored by ST Pharm Co..
NCT05869643 is a Phase 2 study of HIV-1-infection that is actively recruiting participants, run by ST Pharm Co.. The registered enrollment target is 36 participants, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (90% lower). The trial reports 13 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05869643, a Phase 2 study of HIV-1-infection, is actively recruiting participants, sponsored by ST Pharm Co..
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 13
- Study locations
Study 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.
Primary Outcome
Change in plasma HIV-1 RNA log10 copies from baseline to Day 11 following a 10-day treatment period at each dose level.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Low-dose STP0404 (Pirmitegravir)
- DRUG Medium-dose STP0404 (Pirmitegravir)
- DRUG High-dose STP0404 (Pirmitegravir)
Study Locations (13)
Florida
- Midway Immunology and Research Center - Ft. Pierce
- Schiff Center for Liver Diseases/University of Miami - Miami
- Orlando Immunology Center - Orlando
- USF Health South Tampa Center for Advanced Healthcare - Tampa
California
- Kaiser Permenente Los Angeles Medical Center - Los Angeles
- Ruane Clinical Research, Inc. - Los Angeles
New Jersey
- Saint Michael's Medical Center - Newark
- South Jersey Infectious Disease - Somers Point
Texas
- St Hope Foundation, Inc - Bellaire
- North Texas Infectious Diseases Consultants, P.A. - Dallas
Michigan
- Be Well Medical Center - Berkley
New York
- North Shore University Hospital - Manhasset
North Carolina
- Atrium Health Wake Forest Baptist Medical Center - PPDS - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2023-05-23 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 2 |
What NCT05869643 shows while recruiting
NCT05869643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (90% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT05869643 lists 13 locations in 7 states (Florida, California, New Jersey).
Frequently Asked Questions
What is clinical trial NCT05869643 about?
NCT05869643 is a clinical study titled "A Clinical Trial of STP0404 in Adults With HIV-1 Infection". 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.
What is the current status of trial NCT05869643?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2023-05-23. Estimated completion is 2026-04-30.
What conditions does trial NCT05869643 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT05869643?
The interventions under investigation include: Placebo (DRUG), Low-dose STP0404 (Pirmitegravir) (DRUG), Medium-dose STP0404 (Pirmitegravir) (DRUG), High-dose STP0404 (Pirmitegravir) (DRUG).
Who is sponsoring clinical trial NCT05869643?
This trial is sponsored by ST Pharm Co., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05869643 being conducted?
This trial has 13 study locations across California, Florida, Michigan, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05869643's enrollment target sits among peer trials
36 53rd of 71 higher than 18 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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