PH2a, VH3739937 Proof-Of-Concept in TN HIV-1 Infected Adults

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Viiv Healthcare UK Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

21 Dec 2023 → 18 Mar 2025

Decision date (initial)

2023-12-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

GSK Pharma R&D

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Dose response, Pharmacodynamic, Pharmacokinetic, Efficacy

To evaluate the antiviral activity of VH3739937 in HIV-1 infected treatment-naive (TN) participants during 7 days of monotherapy

Secondary objectives 2

1. To assess the safety and tolerability of VH3739937 when administered as monotherapy over 7 days in HIV-1 infected TN participants
2. To characterize the pharmacokinetics of VH3739937 in HIV-1 infected TN participants

Conditions and MedDRA coding

HIV Infections

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Participants aged 18 to 65 years of age inclusive at the time of signing the informed consent
2. Participants who are overtly healthy (other than HIV infection)
3. Screening CD4+ T-cell count >=200 cells/mm3
4. Documented HIV infection and Screening plasma HIV-1 RNA >=3000 and <1,000,000 copies/mL.
5. Positive HIV antibody test
6. Treatment naive: No antiretroviral therapies (in combination or monotherapy) received after HIV-1 diagnosis
7. Body weight ≥50.0 kg (110 lbs.) for men and ≥45.0 kg (99 lbs) for women and BMI for all participants within the range 18.5-35.0 kg/m2
8. Participants who were considered female at birth must be of non-childbearing potential
9. Capable of giving signed informed consent
10. Participant must be willing and able to start a commercially available standard of care antiretroviral treatment regimen on Study Day 8 .

Exclusion criteria 19

1. Any evidence of an active CDC Stage 3 disease
2. Ongoing malignancy other than certain localized malignancies
3. History of significant underlying psychiatric disorder or a clinical assessment of suicidality. History of suicidal behavior and/or ideation should be considered when evaluating suicide risk
4. History of major depressive disorder with or without suicidal features, or anxiety disorders that required medical intervention.
5. Any pre-existing physical or other psychiatric condition (including alcohol or drug abuse) which may interfere with participant's ability to comply with the protocol and dosing schedule
6. Current or chronic history of liver disease
7. Primary HIV infection
8. Pre-existing condition that could interfere with normal gastrointestinal anatomy or motility, hepatic and/or renal function that could impact the absorption, metabolism, and/or excretion of the study interventions.
9. Myocardial infarction, acute coronary syndrome, unstable angina, stroke, TIA, or intermittent claudication in the past 3 months.
10. Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome or sudden cardiac death. Has an exclusionary ECG finding.
11. Previous exposure to a maturation inhibitor
12. Has been exposed to any prohibited or exclusionary medication or vaccine.
13. History of sensitivity to any of the study interventions or their components.
14. Exposure to an experimental medication or vaccine within 28 days or 5 half-lives (which is longer) before the first dose of study intervention.
15. Has untreated syphilis infection
16. Is positive for Hepatitis B or C
17. Has exclusionary safety laboratory test results (e.g., Grade 3 or greater abnormality)
18. Has a positive result for illicit drug use, regular use of drugs of abuse
19. Sensitivity to heparin or heparin-induced thrombocytopenia

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Maximum change from baseline (Day 1) in plasma HIV-1 RNA through Day 8

Secondary endpoints 2

1. Incidence of SAEs, Deaths and AEs leading to Discontinuation through Day 8
2. VH3739937 PK parameters : Following QD dosing: • Day 1: Cmax, tmax, C24 and AUC(0 24) • Day 7: Cmax,ss, tmax, C24,ss and AUC(0-24),ss Following single dose: Cmax, tmax, AUC(0-168) and C168

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Viiv Healthcare UK Limited

Sponsor organisation

Viiv Healthcare UK Limited

Address

980 Great West Road

City

Brentford

Postcode

TW8 9GS

Country

United Kingdom

Scientific contact point

Organisation

Viiv Healthcare UK Limited

Contact name

EU GSK Clinical Trials Call Center

Public contact point

Organisation

Viiv Healthcare UK Limited

Contact name

EU GSK Clinical Trials Call Center

Third parties 10

Locations

4 EU/EEA countries · 16 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 3 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications