Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults
NCT ID: NCT06039579
Last Updated: 2025-09-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2023-10-25
2024-06-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part 1a: VH4004280 Dose Level 1
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
VH4004280
VH4004280 was administered as tablets orally at Day 1.
Antiretroviral therapy
Antiretroviral therapy was administered as available and as per investigator's recommendation.
Part 1a: VH4004280 Dose Level 2
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
VH4004280
VH4004280 was administered as tablets orally at Day 1.
Antiretroviral therapy
Antiretroviral therapy was administered as available and as per investigator's recommendation.
Part 2a: VH4004280 pre-specified dose
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
VH4004280
VH4004280 was administered as tablets orally at Day 1.
Antiretroviral therapy
Antiretroviral therapy was administered as available and as per investigator's recommendation.
Matching placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
VH4004280 Matching Placebo
VH4004280 Matching Placebo was administered as tablets orally at Day 1.
Antiretroviral therapy
Antiretroviral therapy was administered as available and as per investigator's recommendation.
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
VH4011499
VH4011499 was administered as tablets orally at Day 1 and Day 6.
Antiretroviral therapy
Antiretroviral therapy was administered as available and as per investigator's recommendation.
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
VH4011499
VH4011499 was administered as tablets orally at Day 1 and Day 6.
VH4011499 Matching Placebo
VH4011499 Matching Placebo was administered as tablets orally at Day 1 and Day 6.
Antiretroviral therapy
Antiretroviral therapy was administered as available and as per investigator's recommendation.
Part 2b: VH4011499 pre-specified dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
VH4011499
VH4011499 was administered as tablets orally at Day 1 and Day 6.
Antiretroviral therapy
Antiretroviral therapy was administered as available and as per investigator's recommendation.
Matching placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Antiretroviral therapy
Antiretroviral therapy was administered as available and as per investigator's recommendation.
Interventions
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VH4004280
VH4004280 was administered as tablets orally at Day 1.
VH4011499
VH4011499 was administered as tablets orally at Day 1 and Day 6.
VH4004280 Matching Placebo
VH4004280 Matching Placebo was administered as tablets orally at Day 1.
VH4011499 Matching Placebo
VH4011499 Matching Placebo was administered as tablets orally at Day 1 and Day 6.
Antiretroviral therapy
Antiretroviral therapy was administered as available and as per investigator's recommendation.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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ViiV Healthcare
INDUSTRY
Responsible Party
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Locations
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GSK Investigational Site
Bakersfield, California, United States
GSK Investigational Site
DeLand, Florida, United States
GSK Investigational Site
Newark, New Jersey, United States
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Ciudad Autonoma de Bueno, , Argentina
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Marseille, , France
GSK Investigational Site
Nantes, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Cologne, , Germany
GSK Investigational Site
Milan, , Italy
GSK Investigational Site
Guadalajara, , Mexico
GSK Investigational Site
Mexico City, , Mexico
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2023-505350-18-00
Identifier Type: OTHER
Identifier Source: secondary_id
218307
Identifier Type: -
Identifier Source: org_study_id
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