A Randomized, Double-Blind (Sponsor-Unblinded), Placebo-Controlled, Adaptive Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in Treatment-Naïve Adults Living With HIV-1

TerminadoFase 2ClinicalTrials.gov

ID: NCT06061081Tipo: INTERVENTIONALInicio: 21 de dic de 2023Fin estimado: 27 de ago de 2024

Traducción no disponible, mostrando original

Resumen

The primary purpose of this study is to assess the antiviral activity of VH3739937 in Human Immunodeficiency Virus Type-1 (HIV-1) infected treatment naive (TN) participants during monotherapy.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

Participants who are overtly healthy (other than HIV infection) as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
Positive HIV antibody test
Treatment-naïve: No Antiretrovirals (ARVs) (in combination or monotherapy) received after the diagnosis of HIV-1 infection
Body weight ≥50.0 kilogram (kg) (110 pounds \[lbs\]) for men and ≥45.0 kg (99 lbs) for women and BMI for all participants within the range 18.5-35.0 kilogram per meter square (kg/m\^2).
Capable of giving signed informed consent
Participant must be willing and able to start Combination Antiretrovial Therapy (cART) as selected with the Investigator on Study Day 8 (except in the case of early termination, clinically relevant AE/SAE, lab abnormality, the withdrawal of consent, lost to follow-up, etc., where circumstances could dictate otherwise).

Criterios de exclusión

Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
Participants with primary HIV infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue, etc) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion
Myocardial infarction, acute coronary syndrome, unstable angina, stroke, transient ischemic attack, or intermittent claudication in the past 3 months
The participant has received an investigational HIV vaccine (immunotherapeutic or immunomodulatory)
Regular use of drugs of abuse
Sensitivity to heparin or heparin-induced thrombocytopenia

Intervenciones

drug

VH3739937

VH3739937 will be administered.

drug

Placebo

Placebo will be administered.

Ubicaciones

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Rosario, Argentina

Patrocinadores

PrincipalViiV Healthcare

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Randomized, Double-Blind (Sponsor-Unblinded), Placebo-C... | EligiMed