NCT06039579CompletedPhase 2
Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults
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
Source: ClinicalTrials.gov · Last updated 30 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 23 Aug 2023
- Start date
- 25 Oct 2023
- Primary completion date
- 24 Jun 2024
- Lead sponsor
- ViiV Healthcare
- Diseases
- HIV
- NCT number
- NCT06039579
- EU CT number
- 2023-505350-18-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 44
- From 25 Oct 2023 to the primary completion date, 24 Jun 2024
- 28 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with immunomodulating agents or any agent with known anti-HIV activity.
- Participants who have been exposed to any prohibited medication or vaccine.
- Participants who have positive results for illicit drug use, regular use of drugs of abuse and/or excessive alcohol use.
Other illness
- 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.
- 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.
- Participant positive for hepatitis B or hepatitis C.
Lab values
- Participants with exclusionary safety laboratory (e.g Grade 3 or greater abnormality).
Other
- Women who are breastfeeding or plan to become pregnant or breast feed during the study.
- Participants having exclusionary electrocardiogram (ECG) findings.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Ciudad Autonoma de Bueno | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Completed |
| Universitaetsklinikum Duesseldorf AöR Coordinator of this site? Confirm its status | Duesseldorf | Germany | Completed |
| ICH Study Center Gmbh & Co. KG Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Completed |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hopital Europeen Marseille Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Completed |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 18 | France | Completed |
| Centre Hospitalier De Tourcoing Coordinator of this site? Confirm its status | Tourcoing Cedex | France | Completed |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| ASST Fatebenefratelli Sacco Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| National Institute For Infectious Diseases Lazzaro Spallanzani Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Azienda Sanitaria Locale Citta Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Completed |
| - Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| - Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| - Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| - Coordinator of this site? Confirm its status | DeLand | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
Related publications
- Antiviral Effect, Safety, and Tolerability of Oral VH4011499 (VH-499), a New HIV-1 Capsid Inhibitor: Proof-of-Concept Trial.Clin Infect Dis · 2026 · PMID 42525562
This page is information, not medical advice. Discuss any trial with your doctor.