Proof of concept treatment study of orally administered VH4004280 or VH4011499 in 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

15 Dec 2023 → 24 Jun 2024

Decision date (initial)

2023-12-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

ViiV Healthcare UK Ltd

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Others, Efficacy

To evaluate the antiviral activity of orally administered VH4004280 and VH4011499 monotherapy over 10 days in HIV-1 infected Treatment-Naïve participants

Secondary objectives 3

1. To assess the safety and tolerability of orally administered VH4004280 and VH4011499
2. To characterize the pharmacokinetic profiles of orally administered VH4004280 and VH4011499
3. To determine the relationship between the exposure levels of orally administered VH4004280 and VH4011499 and change in plasma HIV-1 RNA

Conditions and MedDRA coding

HIV Infections

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Are 18 to 65 years of age
2. Are overtly healthy (other than HIV-1 infection)
3. Have screening CD4+ T-cell counts >=200 cells/µL.
4. Have documented HIV-1 infection and Screening plasma HIV-1 RNA >=3000 copies/mL
5. Are treatment-naïve: Prior use of oral PreP is permitted and meets inclusion. Prior use of parenteral PreP is exclusionary
6. Has BMI within the range 18.5-31.0 kg/m2.
7. 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
8. Are capable of giving signed informed consent
9. Are willing and able to start locally accessible and commercially available combination antiretroviral therapy on Study Day 11.

Exclusion criteria 13

1. Are breastfeeding or plan to become pregnant or breast feed during the study.
2. Participants with acute HIV infection
3. Any evidence of an active CDC Stage 3 disease.
4. Ongoing malignancy other than certain localized malignancies
5. Treatment with immunomodulating agents or any agent with known anti-HIV activity.
6. Has exclusionary psychiatric, hepatic, cardiovascular gastrointestinal, renal condition
7. Has a 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 the medication.
8. Has an exclusionary ECG finding.
9. Has been exposed to any prohibited medication or vaccine.
10. Has untreated syphilis infection.
11. Is positive for hepatitis B or hepatitis C.
12. Has exclusionary safety laboratory (e.g Grade 3 or greater abnormality).
13. Is positive result for illicit drug use, regular use of drugs of abuse and/or excessive alcohol use

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Maximum change from baseline (Day 1) in plasma HIV-1 ribonucleic acid through Day 11.

Secondary endpoints 3

1. • Incidence of adverse events (AEs), severity of AEs and AEs leading to study treatment discontinuation • Change from baseline and maximum toxicity grade increase from baseline for liver panel laboratory parameters
2. PK measures that include but are not limited to: • Maximum observed plasma drug concentration (Cmax), • Time to maximum observed plasma drug concentration (tmax), • Concentrations on Day 11 for VH4004280 and VH4011499
3. VH4004280 and VH4011499 PK parameters with maximum change in plasma HIV-1 RNA from baseline through Day 11

Investigational products

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

Test 4

Placebo 2

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 13

Locations

4 EU/EEA countries · 19 investigational sites

By country

Investigational sites

Country notifications

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

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 6 files

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

Application history

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