HIV InfectionsPhase 2CINNAMONNCT06039579
Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults
A Phase 2 study testing VH4004280, VH4011499 and Antiretroviral therapy in people with HIV Infections, run by ViiV Healthcare at 20 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- VH4004280, VH4011499 and Antiretroviral therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 20 sitesin 9 countries
- Study dates
- 25 Oct 2023to 24 Jun 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
20 sites in 9 countries.
20 sites in 9 countries
Argentina4 sites
GSK Investigational Site
Buenos Aires, 1023
GSK Investigational Site
Buenos Aires, C1202ABB
GSK Investigational Site
Buenos Aires, C1425AGC
GSK Investigational Site
Ciudad Autonoma de Bueno, C1405CKC
Spain4 sites
GSK Investigational Site
Barcelona, 08907
GSK Investigational Site
Barcelona, 08916
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Madrid, 28046
United States3 sites
GSK Investigational Site
Bakersfield, California, 93301
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
Newark, New Jersey, 07102
France3 sites
GSK Investigational Site
Marseille, 13003
GSK Investigational Site
Nantes, 44093
GSK Investigational Site
Paris, 75018
Mexico2 sites
GSK Investigational Site
Guadalajara, 44160
GSK Investigational Site
Mexico City, 06760
About this study
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
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.
- Conditions
- HIV Infections
- Being tested
- VH4004280, VH4011499, VH4004280 Matching Placebo, VH4011499 Matching Placebo, Antiretroviral therapy
- Keywords
- HIV-1, VH4004280, VH4011499, Treatment Naïve, Phase 2a, Monotherapy
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VH4004280Drug
VH4004280 was administered as tablets orally at Day 1.
VH4011499Drug
VH4011499 was administered as tablets orally at Day 1 and Day 6.
VH4004280 Matching PlaceboDrug
VH4004280 Matching Placebo was administered as tablets orally at Day 1.
VH4011499 Matching PlaceboDrug
VH4011499 Matching Placebo was administered as tablets orally at Day 1 and Day 6.
Antiretroviral therapyDrug
Antiretroviral therapy was administered as available and as per investigator's recommendation.
| Study group | Role | What they receive |
|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Experimental | 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. Receives: Drug: VH4004280; Drug: Antiretroviral therapy |
| Part 1a: VH4004280 Dose Level 2 | Experimental | 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. Receives: Drug: VH4004280; Drug: Antiretroviral therapy |
| Part 2a: VH4004280 pre-specified dose | Experimental | 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. Receives: Drug: VH4004280; Drug: Antiretroviral therapy |
| Matching placebo for VH4004280 | Placebo comparator | 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. Receives: Drug: VH4004280 Matching Placebo; Drug: Antiretroviral therapy |
| Part 1b: VH4011499 Dose Level 1 | Experimental | 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. Receives: Drug: VH4011499; Drug: Antiretroviral therapy |
| Part 1b: VH4011499 Dose Level 2 | Experimental | 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. Receives: Drug: VH4011499; Drug: VH4011499 Matching Placebo; Drug: Antiretroviral therapy |
| Part 2b: VH4011499 pre-specified dose | Experimental | 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. Receives: Drug: VH4011499; Drug: Antiretroviral therapy |
| Matching placebo for VH4011499 | Placebo comparator | 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. Receives: Drug: Antiretroviral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: From Baseline (Day 1) and up to Day 11
Secondary outcomes (21)
Monotherapy: Number of Participants With Any Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any = occurrence of the event regardless of intensity grade or relation to the study intervention.
Measured: From Baseline (Day 1) and up to Day 11
Follow-up: Number of Participants With Any AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any = occurrence of the event regardless of intensity grade or relation to the study intervention.
Measured: From Day 11 and up to Day 39
Monotherapy: Number of Participants With AEs by Severity
Severity was rated according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.
Measured: From Baseline (Day 1) and up to Day 11
Follow-up: Number of Participants With AEs by Severity
Severity was rated according to the DAIDS grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.
Measured: From Day 11 and up to Day 39
Monotherapy: Number of Participants With AEs Leading to Study Treatment Discontinuation
'Discontinuation' of study intervention refers to any participant who has not received all planned doses of study intervention.
Measured: From Baseline (Day 1) and up to Day 11
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Change from Baseline values for liver panel laboratory parameters total bilirubin and direct bilirubin were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.Standard deviation (SD) = 0.0000 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.0000.
Measured: At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Change from Baseline values for liver panel laboratory parameters total bilirubin and direct bilirubin were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value. SD = 0.0000 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.0000.
Measured: At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
Change from Baseline values for liver panel laboratory parameters ALT, ALP and AST were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Measured: At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
Change from Baseline values for liver panel laboratory parameters ALT, ALP and AST were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Measured: At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Laboratory abnormalities were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences.
Measured: From Baseline (Day 1) and up to Day 39
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Laboratory abnormalities were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences.
Measured: From Baseline (Day 1) and up to Day 39
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
Laboratory abnormalities were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences.
Measured: From Baseline (Day 1) and up to Day 39
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
Laboratory abnormalities were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences.
Measured: From Baseline (Day 1) and up to Day 39
Monotherapy, VH4004280: Maximum Observed Plasma Drug Concentration (Cmax)
Cmax is defined as the maximum concentration of the drug in plasma.
Measured: After dose administration at Day 1
Monotherapy, VH4011499: Cmax
Cmax is defined as the maximum concentration of the drug in plasma.
Measured: After dose administration at Day 1 and Day 6
Monotherapy, VH4004280: Time to Maximum Observed Plasma Drug Concentration (Tmax)
Tmax is a measure of the time required to reach the maximum concentration of the drug.
Measured: After dose administration at Day 1
Monotherapy, VH4011499: Tmax
Tmax is a measure of the time required to reach the maximum concentration of the drug.
Measured: After dose administration at Day 1 and Day 6
Monotherapy, VH4004280: Plasma Concentration at Day 11 (C11)
C11 is defined as the concentration of the drug in plasma at Day 11.
Measured: At Day 11
Monotherapy, VH4011499: C11
C11 is defined as the concentration of the drug in plasma at Day 11.
Measured: At Day 11
Monotherapy, VH4004280: Change in Plasma HIV-1 RNA From Baseline
Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Measured: At Baseline (Day 1) and Day 11
Monotherapy, VH4011499: Change in Plasma HIV-1 RNA From Baseline
Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Measured: At Baseline (Day 1) and Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start25 Oct 2023
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039579
- Sponsor's protocol ID
- 218307
- Other IDs
- 2023-505350-18-00, 2023
- Acronym
- CINNAMON
- Status last verified
- Sep 2025
- First submitted
- 23 Aug 2023
- Last updated
- 30 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Griesel R, Nunez SA, Cordova E, Perez Rios AM, Ridilenir VL, Lehmann C, Slim J, Arenzana CB, Szabo J, Cahn P, Post FA, Pierce A, Pestrak M, Jeffrey JL, Thakkar N, Shepherd B, Bainbridge V, Angelis K, McMillan C, Benn P. Antiviral Effect, Safety, and Tolerability of Oral VH4011499 (VH-499), a New HIV-1 Capsid Inhibitor: Proof-of-Concept Trial. Clin Infect Dis. 2026 Jul 29:ciag452. doi: 10.1093/cid/ciag452. Online ahead of print.
PubMed 42525562
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06039579
- Acronym / sponsor ID
- CINNAMON / 218307
- Conditions
- HIV Infections
- Keywords
- HIV-1, VH4004280, VH4011499, Treatment Naïve, Phase 2a, Monotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 15 Sep 2023 (actual)
- Results
- Posted 30 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1a: VH4004280 Dose Level 1 | Experimental | Drug: VH4004280, Drug: Antiretroviral therapyParticipants 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 | Experimental | Drug: VH4004280, Drug: Antiretroviral therapyParticipants 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 | Experimental | Drug: VH4004280, Drug: Antiretroviral therapyParticipants 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 comparator | Drug: VH4004280 Matching Placebo, Drug: Antiretroviral therapyParticipants 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 | Experimental | Drug: VH4011499, Drug: Antiretroviral therapyParticipants 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 | Experimental | Drug: VH4011499, Drug: VH4011499 Matching Placebo, Drug: Antiretroviral therapyParticipants 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 | Experimental | Drug: VH4011499, Drug: Antiretroviral therapyParticipants 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 comparator | Drug: Antiretroviral therapyParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VH4004280VH4004280 was administered as tablets orally at Day 1. | Drug | Part 1a: VH4004280 Dose Level 1, Part 1a: VH4004280 Dose Level 2, Part 2a: VH4004280 pre-specified dose |
| VH4011499VH4011499 was administered as tablets orally at Day 1 and Day 6. | Drug | Part 1b: VH4011499 Dose Level 1, Part 1b: VH4011499 Dose Level 2, Part 2b: VH4011499 pre-specified dose |
| VH4004280 Matching PlaceboVH4004280 Matching Placebo was administered as tablets orally at Day 1. | Drug | Matching placebo for VH4004280 |
| VH4011499 Matching PlaceboVH4011499 Matching Placebo was administered as tablets orally at Day 1 and Day 6. | Drug | Part 1b: VH4011499 Dose Level 2 |
| Antiretroviral therapyAntiretroviral therapy was administered as available and as per investigator's recommendation. | Drug | Matching placebo for VH4004280, Matching placebo for VH4011499, Part 1a: VH4004280 Dose Level 1, Part 1a: VH4004280 Dose Level 2, Part 1b: VH4011499 Dose Level 1, Part 1b: VH4011499 Dose Level 2, Part 2a: VH4004280 pre-specified dose, Part 2b: VH4011499 pre-specified dose |
Primary outcome
Monotherapy, VH4004280: Maximum Change From Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA) log10
Time frame: From Baseline (Day 1) and up to Day 11
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).
Monotherapy, VH4011499: Maximum Change From Baseline (Day 1) in Plasma HIV-1 RNA log10
Time frame: From Baseline (Day 1) and up to Day 11
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.
21 secondary outcomes
Monotherapy: Number of Participants With Any Adverse Events (AEs)
Time frame: From Baseline (Day 1) and up to Day 11
Follow-up: Number of Participants With Any AEs
Time frame: From Day 11 and up to Day 39
Monotherapy: Number of Participants With AEs by Severity
Time frame: From Baseline (Day 1) and up to Day 11
Follow-up: Number of Participants With AEs by Severity
Time frame: From Day 11 and up to Day 39
Monotherapy: Number of Participants With AEs Leading to Study Treatment Discontinuation
Time frame: From Baseline (Day 1) and up to Day 11
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Time frame: At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Time frame: At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
Time frame: At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
Time frame: At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Time frame: From Baseline (Day 1) and up to Day 39
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Time frame: From Baseline (Day 1) and up to Day 39
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
Time frame: From Baseline (Day 1) and up to Day 39
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
Time frame: From Baseline (Day 1) and up to Day 39
Monotherapy, VH4004280: Maximum Observed Plasma Drug Concentration (Cmax)
Time frame: After dose administration at Day 1
Monotherapy, VH4011499: Cmax
Time frame: After dose administration at Day 1 and Day 6
Monotherapy, VH4004280: Time to Maximum Observed Plasma Drug Concentration (Tmax)
Time frame: After dose administration at Day 1
Monotherapy, VH4011499: Tmax
Time frame: After dose administration at Day 1 and Day 6
Monotherapy, VH4004280: Plasma Concentration at Day 11 (C11)
Time frame: At Day 11
Monotherapy, VH4011499: C11
Time frame: At Day 11
Monotherapy, VH4004280: Change in Plasma HIV-1 RNA From Baseline
Time frame: At Baseline (Day 1) and Day 11
Monotherapy, VH4011499: Change in Plasma HIV-1 RNA From Baseline
Time frame: At Baseline (Day 1) and Day 11
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42525562Griesel R, Nunez SA, Cordova E, Perez Rios AM, Ridilenir VL, Lehmann C, Slim J, Arenzana CB, Szabo J, Cahn P, Post FA, Pierce A, Pestrak M, Jeffrey JL, Thakkar N, Shepherd B, Bainbridge V, Angelis K, McMillan C, Benn P. Antiviral Effect, Safety, and Tolerability of Oral VH4011499 (VH-499), a New HIV-1 Capsid Inhibitor: Proof-of-Concept Trial. Clin Infect Dis. 2026 Jul 29:ciag452. doi: 10.1093/cid/ciag452. Online ahead of print.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VH4004280, VH4011499 and Antiretroviral therapy in people with HIV Infections, run by ViiV Healthcare at 20 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Argentina, Spain, United States, France, Mexico and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monotherapy, VH4004280: Maximum Change From Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA) log10 (time frame: From Baseline (Day 1) and up to Day 11). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06039579, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.