Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults

HIV Infections Clinical Trial

— CINNAMON  

Official title:

A Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled, Phase 2a Trial to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Orally Administered Investigational Capsid Inhibitor Monotherapy in HIV-1 Infected Treatment-Naïve Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06039579
• Other study ID #: 218307
• Secondary ID: 2023-505350-18-0
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 25, 2023
• Est. completion date: June 18, 2024

Study information

• Verified date: June 2024
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of the study is to evaluate the antiviral activity of orally administered VH4004280 and VH4011499 monotherapy over 10 days in human immunodeficiency virus (HIV-1) infected Treatment-Naïve (TN) participants.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: June 18, 2024
• Est. primary completion date: June 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participants who are overtly healthy (other than HIV-1 infection).

• Screening cluster of differentiation-4 (CD4+) T-cell count greater than or equal to (=)200 cells/microliter (µL).

• Documented HIV-1 infection and Screening plasma HIV-1 RNA =3000 copies/milliliter (mL).

• Treatment-naïve: Defined as no antiretroviral therapy received after the diagnosis of HIV-1 infection. Prior use of oral pre-exposure prophylaxis (PreP) is permitted. Prior use of parenteral PreP is exclusionary.

• Has body mass index (BMI) within the range of 18.5-31.0 kilograms per meter square (kg/m^2).

• Participants male at birth must use male condoms and participants female at birth who are of childbearing potential must be using acceptable forms of birth control.

• Participants capable of giving signed informed consent.

• Participant must be willing and able to start locally accessible and commercially available combination antiretroviral therapy after the monotherapy period.

Exclusion Criteria:

• Women who are breastfeeding or plan to become pregnant or breast feed during the study.

• Participants with acute HIV infection.

• Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease.

• Untreated syphilis infection.

• Ongoing malignancy other than certain localised malignancies.

• Treatment with immunomodulating agents or any agent with known anti-HIV activity.

• Has exclusionary psychiatric, hepatic, cardiovascular gastrointestinal, renal condition.

• Participant having any condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to take oral medication.

• Participants having exclusionary electrocardiogram (ECG) findings.

• Participants who have been exposed to any prohibited medication or vaccine.

• Participant positive for hepatitis B or hepatitis C.

• Participants with exclusionary safety laboratory (e.g Grade 3 or greater abnormality).

• Participants who have positive results for illicit drug use, regular use of drugs of abuse and/or excessive alcohol use.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• VH4004280
VH4004280 will be administered.
• VH4011499
VH4011499 will be administered.
• VH4004280 Matching Placebo
VH4004280 matching placebo will be administered.
• VH4011499 Matching Placebo
VH4011499 matching placebo will be administered.

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad de Buenos Aires	Buenos Aires
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Ottawa	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Vancouver	British Columbia
France	GSK Investigational Site	Marseille
France	GSK Investigational Site	Nantes
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Tourcoing Cedex
Germany	GSK Investigational Site	Duesseldorf	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Torino	Piemonte
Mexico	GSK Investigational Site	Chihuahua
Mexico	GSK Investigational Site	Guadalajara, Jalisco	Jalisco
Mexico	GSK Investigational Site	Merida
Mexico	GSK Investigational Site	Mexico City
Spain	GSK Investigational Site	Badalona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Sevilla
United Kingdom	GSK Investigational Site	Liverpool.
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	London
United States	GSK Investigational Site	Bakersfield	California
United States	GSK Investigational Site	DeLand	Florida
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	Newark	New Jersey
United States	GSK Investigational Site	Palm Springs	California
United States	GSK Investigational Site	Vero Beach	Florida
United States	GSK Investigational Site	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
ViiV Healthcare

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  France,  Germany,  Italy,  Mexico,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Change from Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA)		Baseline (Day 1) and up to Day 11
Secondary	Number of Participants with Adverse Events (AE) as per Severity and AEs Leading to Study Treatment Discontinuation		Up to Day 39
Secondary	Change from Baseline for Liver Panel Laboratory Parameters: Total Bilirubin and Direct Bilirubin (Micromoles per Liter [umol/L])		Baseline (Day 1) and up to Day 39
Secondary	Change from Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT) Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) (International Units per Liter)		Baseline (Day 1) and up to Day 39
Secondary	Change in Maximum Toxicity Grade from Baseline for Liver Panel Laboratory Parameters: Total Bilirubin and Direct Bilirubin (umol/L)		Baseline (Day 1) and up to Day 39
Secondary	Change in Maximum Toxicity Grade from Baseline for Liver Panel Laboratory Parameters: ALT, ALP, and AST (International Units per Liter)		Baseline (Day 1) and up to Day 39
Secondary	Maximum Observed Plasma Drug Concentration (Cmax) for VH4004280		Up to Day 39
Secondary	Maximum Observed Plasma Drug Concentration (Cmax) for VH4011499		Up to Day 39
Secondary	Time to Maximum Observed Plasma Drug Concentration (tmax) for VH4004280 (Hours)		Up to Day 39
Secondary	Time to Maximum Observed Plasma Drug Concentration (tmax) for VH4011499 (Hours)		Up to Day 39
Secondary	Plasma Concentrations of VH4004280		At Day 11
Secondary	Plasma Concentrations of VH4011499		At Day 11
Secondary	Change from baseline in plasma HIV-1 RNA relative to concentration on Day 11 (C11) for VH4004280 (copies per milliliter)	Plasma samples will be collected for quantitative analysis of HIV-1 RNA.	Baseline (Day 1) and up to Day 11
Secondary	Change from baseline in plasma HIV-1 RNA relative to concentration on Day 11 (C11) for VH4011499 (copies per milliliter)	Plasma samples will be collected for quantitative analysis of HIV-1 RNA	Baseline (Day 1) and up to Day 11