Skip to main content
OpenTrials
Completed

NCT Number: NCT06039579

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VH4004280

Drug

VH4004280 was administered as tablets orally at Day 1.

VH4011499

Drug

VH4011499 was administered as tablets orally at Day 1 and Day 6.

VH4004280 Matching Placebo

Drug

VH4004280 Matching Placebo was administered as tablets orally at Day 1.

VH4011499 Matching Placebo

Drug

VH4011499 Matching Placebo was administered as tablets orally at Day 1 and Day 6.

Antiretroviral therapy

Drug

Antiretroviral therapy was administered as available and as per investigator's recommendation.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. Monotherapy: Number of Participants With Any Adverse Events (AEs)

    Time frame: From Baseline (Day 1) and up to Day 11

    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.

  2. Follow-up: Number of Participants With Any AEs

    Time frame: From Day 11 and up to Day 39

    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.

  3. Monotherapy: Number of Participants With AEs by Severity

    Time frame: From Baseline (Day 1) and up to Day 11

    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.

  4. Follow-up: Number of Participants With AEs by Severity

    Time frame: From Day 11 and up to Day 39

    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.

  5. Monotherapy: Number of Participants With AEs Leading to Study Treatment Discontinuation

    Time frame: From Baseline (Day 1) and up to Day 11

    'Discontinuation' of study intervention refers to any participant who has not received all planned doses of study intervention.

  6. 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

    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.

  7. 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

    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.

  8. 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

    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.

  9. 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

    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.

  10. 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

    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.

  11. 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

    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.

  12. 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

    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.

  13. 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

    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.

  14. Monotherapy, VH4004280: Maximum Observed Plasma Drug Concentration (Cmax)

    Time frame: After dose administration at Day 1

    Cmax is defined as the maximum concentration of the drug in plasma.

  15. Monotherapy, VH4011499: Cmax

    Time frame: After dose administration at Day 1 and Day 6

    Cmax is defined as the maximum concentration of the drug in plasma.

  16. Monotherapy, VH4004280: Time to Maximum Observed Plasma Drug Concentration (Tmax)

    Time frame: After dose administration at Day 1

    Tmax is a measure of the time required to reach the maximum concentration of the drug.

  17. Monotherapy, VH4011499: Tmax

    Time frame: After dose administration at Day 1 and Day 6

    Tmax is a measure of the time required to reach the maximum concentration of the drug.

  18. Monotherapy, VH4004280: Plasma Concentration at Day 11 (C11)

    Time frame: At Day 11

    C11 is defined as the concentration of the drug in plasma at Day 11.

  19. Monotherapy, VH4011499: C11

    Time frame: At Day 11

    C11 is defined as the concentration of the drug in plasma at Day 11.

  20. Monotherapy, VH4004280: Change in Plasma HIV-1 RNA From Baseline

    Time frame: At Baseline (Day 1) and Day 11

    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.

  21. Monotherapy, VH4011499: Change in Plasma HIV-1 RNA From Baseline

    Time frame: At Baseline (Day 1) and Day 11

    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.

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Registry information

Official study 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

Acronym: CINNAMON

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 15, 2023
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.