Clinical trial NCT06039579: Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV-1
VH4004280
VH4011499
Treatment Naïve
Phase 2a
Monotherapy
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
First posted: 2023-09-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Change from Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA)
timeFrame: Baseline (Day 1) and up to Day 11
Secondary outcomes:
measure: Number of Participants with Adverse Events (AE) as per Severity and AEs Leading to Study Treatment Discontinuation
timeFrame: Up to Day 39
measure: Change from Baseline for Liver Panel Laboratory Parameters: Total Bilirubin and Direct Bilirubin (Micromoles per Liter [umol/L])
timeFrame: Baseline (Day 1) and up to Day 39
measure: Change from Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT) Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) (International Units per Liter)
timeFrame: Baseline (Day 1) and up to Day 39
measure: Change in Maximum Toxicity Grade from Baseline for Liver Panel Laboratory Parameters: Total Bilirubin and Direct Bilirubin (umol/L)
timeFrame: Baseline (Day 1) and up to Day 39
measure: Change in Maximum Toxicity Grade from Baseline for Liver Panel Laboratory Parameters: ALT, ALP, and AST (International Units per Liter)
timeFrame: Baseline (Day 1) and up to Day 39
measure: Maximum Observed Plasma Drug Concentration (Cmax) for VH4004280
timeFrame: Up to Day 39
measure: Maximum Observed Plasma Drug Concentration (Cmax) for VH4011499
timeFrame: Up to Day 39
measure: Time to Maximum Observed Plasma Drug Concentration (tmax) for VH4004280 (Hours)
timeFrame: Up to Day 39
measure: Time to Maximum Observed Plasma Drug Concentration (tmax) for VH4011499 (Hours)
timeFrame: Up to Day 39
measure: Plasma Concentrations of VH4004280
timeFrame: At Day 11
measure: Plasma Concentrations of VH4011499
timeFrame: At Day 11
measure: Change from baseline in plasma HIV-1 RNA relative to concentration on Day 11 (C11) for VH4004280 (copies per milliliter)
timeFrame: Baseline (Day 1) and up to Day 11
measure: Change from baseline in plasma HIV-1 RNA relative to concentration on Day 11 (C11) for VH4011499 (copies per milliliter)
timeFrame: Baseline (Day 1) and up to Day 11
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: GSK Investigational Site
state: California
city: DeLand
country: United States
facility: GSK Investigational Site
state: Florida
city: Newark
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autonoma De Bueno
country: Argentina
facility: GSK Investigational Site
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Marseille
country: France
facility: GSK Investigational Site
city: Nantes cedex 1
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Koeln
country: Germany
facility: GSK Investigational Site
city: Milano
country: Italy
facility: GSK Investigational Site
city: Milano
country: Italy
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
city: Torino
country: Italy
facility: GSK Investigational Site
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
city: Mexico City
country: Mexico
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
References: