Actively Recruiting
First Time in Human Study of Long Acting VH4524184 Formulations
Led by ViiV Healthcare · Updated on 2026-04-20
268
Participants Needed
3
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection.
CONDITIONS
Official Title
First Time in Human Study of Long Acting VH4524184 Formulations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 55 years at consent
- Overtly healthy based on medical history, physical exam, labs, and heart monitoring
- Negative SARS-CoV-2 test at admission to Phase 1 unit
- Able to understand and follow study instructions and schedule
- Body weight at least 50 kg for men and 45 kg for women
- Body mass index 18.5 to 32.0 kg/m² (except cohort A11: 32.1 to 37.0 kg/m²)
- Male or female sex
- Females of childbearing potential must not be pregnant, breastfeeding, and must use highly effective contraception
- Females not of childbearing potential eligible if other criteria met
- Able to provide signed informed consent
You will not qualify if you...
- Clinical conditions affecting drug absorption, metabolism, elimination, or study participation
- Abnormal blood pressure deemed clinically significant
- History of lymphoma, leukemia, or malignancy in past 5 years (except certain skin cancers)
- History of breast cancer in past 10 years
- Current or chronic liver disease or known liver/biliary abnormalities
- History of cardiac arrhythmias, cardiac disease, or long QT syndrome
- Skin conditions interfering with injection or injection site assessment
- History of severe drug or study intervention hypersensitivity
- Need for chronic anticoagulation except low-dose aspirin or hereditary bleeding disorders
- History of seizures
- Known or suspected psychiatric conditions including depression, anxiety, or insomnia
- Positive suicidal ideation screening
- Insufficient muscle mass for intramuscular injections
- Tattoos, implants, or skin piercings interfering with injections or assessments
- High-risk behaviors increasing HIV risk
- Use of medications within 7 days (or 14 days for enzyme inducers) before dosing and during study
- Receipt of live vaccines or COVID-19 vaccines within specified time frames
- Exposure to more than 4 investigational products in past 12 months
- Participation in another investigational study within 30 days or twice biological effect duration
- Blood loss over 500 mL in 56 days from study participation
- Previous participation in this or related study except specified exceptions
- Reduced kidney function (eGFR <60 mL/min) or elevated serum creatinine
- Low hemoglobin levels
- Elevated liver enzymes or bilirubin
- Significant arrhythmias or abnormal ECG findings
- Positive hepatitis B or C tests
- Positive drug or alcohol screening
- Positive HIV antibody test
- Regular alcohol consumption above limits in past 6 months
- Regular use of drugs of abuse
- Smoking or tobacco use in past 6 months
- Sensitivity or allergy to study drugs or components judged unsafe by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
GSK Investigational Site
Lenexa, Kansas, United States, 66219
Actively Recruiting
2
GSK Investigational Site
San Antonio, Texas, United States, 78209
Actively Recruiting
3
GSK Investigational Site
Salt Lake City, Utah, United States, 84124
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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