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

Completed · Phase 2 · Has a placebo group

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT06039579

Run by

ViiV Healthcare

People needed

44

Starts

2023-10-25

Expected to finish

2024-06-24

Last updated by the study team

2025-09-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Bakersfield, California, United States
• GSK Investigational Site — DeLand, Florida, United States
• GSK Investigational Site — Newark, New Jersey, United States
• GSK Investigational Site — Buenos Aires, Argentina
• GSK Investigational Site — Buenos Aires, Argentina
• GSK Investigational Site — Buenos Aires, Argentina
• GSK Investigational Site — Ciudad Autonoma de Bueno, Argentina
• GSK Investigational Site — Montreal, Quebec, Canada
• GSK Investigational Site — Marseille, France
• GSK Investigational Site — Nantes, France
• GSK Investigational Site — Paris, France
• GSK Investigational Site — Cologne, Germany
• GSK Investigational Site — Milan, Italy
• GSK Investigational Site — Guadalajara, Mexico
• GSK Investigational Site — Mexico City, Mexico
• GSK Investigational Site — Barcelona, Spain
• GSK Investigational Site — Barcelona, Spain
• GSK Investigational Site — Madrid, Spain
• GSK Investigational Site — Madrid, Spain
• GSK Investigational Site — London, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.