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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

Full criteria on ClinicalTrials.gov

Sites (28)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
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Ciudad Autonoma de BuenoArgentinaUnknown status
-
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MontrealCanadaUnknown status
University Hospital Cologne AöR
Coordinator of this site? Confirm its status
CologneGermanyCompleted
Universitaetsklinikum Duesseldorf AöR
Coordinator of this site? Confirm its status
DuesseldorfGermanyCompleted
ICH Study Center Gmbh & Co. KG
Coordinator of this site? Confirm its status
HamburgGermanyCompleted
Hospital Germans Trias i Pujol
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BadalonaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainCompleted
Hospital Clínico San Carlos
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MadridSpainCompleted
Hospital Universitario Ramón y Cajal
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MadridSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Hopital Europeen Marseille
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MarseilleFranceCompleted
Centre Hospitalier Universitaire de Nantes
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NantesFranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceCompleted
Centre Hospitalier De Tourcoing
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Tourcoing CedexFranceCompleted
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LondonUnited KingdomUnknown status
ASST Fatebenefratelli Sacco
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MilanItalyCompleted
Ospedale San Raffaele S.r.l.
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MilanItalyCompleted
National Institute For Infectious Diseases Lazzaro Spallanzani
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RomeItalyCompleted
Azienda Sanitaria Locale Citta Di Torino
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TurinItalyCompleted
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GuadalajaraMexicoUnknown status
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Mexico CityMexicoUnknown status
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BakersfieldUnited StatesUnknown status
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DeLandUnited StatesUnknown status
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NewarkUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.