Phase 2
Completed N=44
Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults
Source: ClinicalTrials.gov NCT06039579 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: Monotherapy, VH4004280: Maximum Change From Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA) log10 — 5.004; 4.923; 4.866; 4.636 log10 c/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Monotherapy, VH4004280: Maximum Change From Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA) log10 |
5.004; 4.923; 4.866; 4.636; -1.056; -1.391 | — |
| PRIMARY Monotherapy, VH4011499: Maximum Change From Baseline (Day 1) in Plasma HIV-1 RNA log10 |
5.001; 4.339; 4.960; 4.714; -1.834; -1.797 | — |
| SECONDARY Monotherapy: Number of Participants With Any Adverse Events (AEs) |
3; 2; 2; 2; 2; 4 | — |
| SECONDARY Follow-up: Number of Participants With Any AEs |
1; 3; 4; 1; 3; 3 | — |
| SECONDARY Monotherapy: Number of Participants With AEs by Severity |
0; 2; 1; 1; 1; 3 | — |
| SECONDARY Follow-up: Number of Participants With AEs by Severity |
1; 1; 1; 0; 2; 1 | — |
| SECONDARY Monotherapy: Number of Participants With AEs Leading to Study Treatment Discontinuation |
0; 0; 0; 0 | — |
| SECONDARY Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin |
6.641; 8.408; 6.926; 6.783; -0.143; -0.513 | — |
| SECONDARY Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin |
5.643; 7.524; 4.544; 7.011; -0.928; 0.114 | — |
| SECONDARY Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) |
31.3; 21.7; 33.2; 52.7; -2.8; -1.8 | — |
| SECONDARY Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST |
14.9; 19.5; 31.7; 18.3; 1.7; -1.2 | — |
| SECONDARY 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 |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY 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 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST |
1; 0; 1; 0; 0; 0 | — |
| SECONDARY Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST |
0; 0; 1; 1; 0; 0 | — |
| SECONDARY Monotherapy, VH4004280: Maximum Observed Plasma Drug Concentration (Cmax) |
131.57; 364.70; 473.00 | — |
| SECONDARY Monotherapy, VH4011499: Cmax |
27.63; 31.88; 133.59; 35.30; 32.31; 141.18 | — |
| SECONDARY Monotherapy, VH4004280: Time to Maximum Observed Plasma Drug Concentration (Tmax) |
7.95; 9.00; 8.04 | — |
| SECONDARY Monotherapy, VH4011499: Tmax |
9.95; 9.88; 8.00; 10.00; 10.04; 11.52 | — |
| SECONDARY Monotherapy, VH4004280: Plasma Concentration at Day 11 (C11) |
18.07; 48.53; 50.42 | — |
| SECONDARY Monotherapy, VH4011499: C11 |
11.16; 10.56; 27.04 | — |
| SECONDARY Monotherapy, VH4004280: Change in Plasma HIV-1 RNA From Baseline |
5.004; 4.923; 4.866; -0.941; -1.322; -1.939 | — |
| SECONDARY Monotherapy, VH4011499: Change in Plasma HIV-1 RNA From Baseline |
5.001; 4.339; 4.960; -1.801; -1.750; -2.165 | — |
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.
Data sourced from ClinicalTrials.gov (NCT06039579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.