Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults
CINNAMON
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
2 other identifiers
interventional
44
9 countries
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
Started Oct 2023
Shorter than P25 for phase_2 hiv-infections
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2023
CompletedFirst Posted
Study publicly available on registry
September 15, 2023
CompletedStudy Start
First participant enrolled
October 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2024
CompletedResults Posted
Study results publicly available
September 30, 2025
CompletedSeptember 30, 2025
September 1, 2025
8 months
August 23, 2023
June 23, 2025
September 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Monotherapy, VH4004280: Maximum Change From Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA) log10
Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. Maximum change from baseline was calculated by subtracting the baseline value from the post-dose visit value when the plasma HIV-1 RNA reached its minimum level up to Day 11 (inclusive). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. The results were expressed as log10 copies per milliliter (log10 c/mL).
From Baseline (Day 1) and up to Day 11
Monotherapy, VH4011499: Maximum Change From Baseline (Day 1) in Plasma HIV-1 RNA log10
Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. Maximum change from baseline was calculated by subtracting the baseline value from the post-dose visit value when the plasma HIV-1 RNA reached its minimum level up to Day 11 (inclusive). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
From Baseline (Day 1) and up to Day 11
Secondary Outcomes (21)
Monotherapy: Number of Participants With Any Adverse Events (AEs)
From Baseline (Day 1) and up to Day 11
Follow-up: Number of Participants With Any AEs
From Day 11 and up to Day 39
Monotherapy: Number of Participants With AEs by Severity
From Baseline (Day 1) and up to Day 11
Follow-up: Number of Participants With AEs by Severity
From Day 11 and up to Day 39
Monotherapy: Number of Participants With AEs Leading to Study Treatment Discontinuation
From Baseline (Day 1) and up to Day 11
- +16 more secondary outcomes
Study Arms (8)
Part 1a: VH4004280 Dose Level 1
EXPERIMENTALParticipants 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.
Part 1a: VH4004280 Dose Level 2
EXPERIMENTALParticipants 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.
Part 2a: VH4004280 pre-specified dose
EXPERIMENTALParticipants 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.
Matching placebo for VH4004280
PLACEBO COMPARATORParticipants 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.
Part 1b: VH4011499 Dose Level 1
EXPERIMENTALParticipants 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.
Part 1b: VH4011499 Dose Level 2
EXPERIMENTALParticipants 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.
Part 2b: VH4011499 pre-specified dose
EXPERIMENTALParticipants 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.
Matching placebo for VH4011499
PLACEBO COMPARATORParticipants 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.
Interventions
VH4004280 was administered as tablets orally at Day 1.
VH4011499 was administered as tablets orally at Day 1 and Day 6.
VH4004280 Matching Placebo was administered as tablets orally at Day 1.
VH4011499 Matching Placebo was administered as tablets orally at Day 1 and Day 6.
Antiretroviral therapy was administered as available and as per investigator's recommendation.
Eligibility Criteria
You may qualify if:
- 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).
- 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.
You may not qualify if:
- 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.
- 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 who have been exposed to any prohibited medication or vaccine.
- Participant positive for hepatitis B or hepatitis C.
- Participants who have positive results for illicit drug use, regular use of drugs of abuse and/or excessive alcohol use.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
Study Sites (20)
GSK Investigational Site
Bakersfield, California, 93301, United States
GSK Investigational Site
DeLand, Florida, 32720, United States
GSK Investigational Site
Newark, New Jersey, 07102, United States
GSK Investigational Site
Buenos Aires, 1023, Argentina
GSK Investigational Site
Buenos Aires, C1202ABB, Argentina
GSK Investigational Site
Buenos Aires, C1425AGC, Argentina
GSK Investigational Site
Ciudad Autonoma de Bueno, C1405CKC, Argentina
GSK Investigational Site
Montreal, Quebec, H2L 4P9, Canada
GSK Investigational Site
Marseille, 13003, France
GSK Investigational Site
Nantes, 44093, France
GSK Investigational Site
Paris, 75018, France
GSK Investigational Site
Cologne, 50937, Germany
GSK Investigational Site
Milan, 20157, Italy
GSK Investigational Site
Guadalajara, 44160, Mexico
GSK Investigational Site
Mexico City, 06760, Mexico
GSK Investigational Site
Barcelona, 08907, Spain
GSK Investigational Site
Barcelona, 08916, Spain
GSK Investigational Site
Madrid, 28034, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
London, SE5 8RX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- ViiV Healthcare
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2023
First Posted
September 15, 2023
Study Start
October 25, 2023
Primary Completion
June 24, 2024
Study Completion
June 24, 2024
Last Updated
September 30, 2025
Results First Posted
September 30, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
- Access Criteria
- Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
The sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to: https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf.