A Phase 2b Study Evaluating VH4011499 Capsid Inhibitor Long-Acting Injectable Plus Cabotegravir in Treatment Naïve Adults (CINERGY) (CINERGY)

September 6, 2026 updated by: ViiV Healthcare

A Phase 2b Randomized, Open-Label Active Controlled Study Evaluating the Safety and Efficacy of 2-drug Injectable Regimens of VH4011499 Plus Cabotegravir in Treatment Naïve Viremic Adult Participants With HIV-1 (CINERGY)

The purpose of this Phase 2b study is to evaluate the efficacy and therapeutic window of chronically dosed VH4011499 paired with an integrase strand transfer inhibitor (INSTI). This study will explore 4 different regimens of VH4011499 when paired with cabotegravir (CAB) as an initial two-drug regimen.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant must be at least 18 years of age (or older, if required for adults by local regulations).
  • Screening CD4+ T-cell count ≥ 200 cells/µL.

  • Documented HIV-1 infection and screening plasma HIV-1 RNA ≥

    1 000 and ≤ 100 000 copies/mL.

  • Treatment-naïve. Prior use of oral pre-exposure prophylaxis (PrEP) or oral post-exposure prophylaxis (PEP) that is not INSTI or CAI based is permitted.
  • Body weight ≥ 50.0 kg (110 lbs) for participants assigned male at birth and ≥ 45.0 kg (99 lbs) for participants assigned female at birth.
  • Agrees to adequate birth control if a participant of childbearing potential

Exclusion Criteria:

  • Participants with acute HIV-1 infection
  • Prior exposure to any HIV-1 capsid inhibitor or any HIV-1 INSTI for any reason is prohibited.
  • Participants with known or suspected presence of major virologic resistance mutations to study drugs
  • Unstable liver disease
  • Participants with HCV co-infection
  • Participant has evidence of chronic active HBV infection
  • Clinically significant cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VH4011499 dose Group 1 + CAB
Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 1, which differs from all other arms) and cabotegravir (CAB).
Drug: VH4011499
Participants receive injectable VH4011499 at different dose groups.
Drug: CAB
Participants receive injectable CAB.
Experimental: VH4011499 dose Group 2 + CAB
Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 2, which differs from all other arms) and CAB.
Drug: VH4011499
Participants receive injectable VH4011499 at different dose groups.
Drug: CAB
Participants receive injectable CAB.
Experimental: VH4011499 dose Group 3 + CAB
Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 3, which differs from all other arms) and CAB.
Drug: VH4011499
Participants receive injectable VH4011499 at different dose groups.
Drug: CAB
Participants receive injectable CAB.
Experimental: VH4011499 dose Group 4 + CAB
Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 4, which differs from all other arms) and CAB.
Drug: VH4011499
Participants receive injectable VH4011499 at different dose groups.
Drug: CAB
Participants receive injectable CAB.
Active Comparator: DTG/3TC
Active control arm receiving daily oral standard of care antiretroviral therapy (dolutegravir 50 mg / lamivudine 300 mg single-tablet regimen).
Drug: DTG/3TC
Participants receive DTG/3TC orally once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with plasma HIV-1 RNA <50 copies/mL as per FDA snapshot algorithm
Time Frame: At Month 7
At Month 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with plasma HIV-1 RNA <50 copies/mL as per FDA snapshot algorithm
Time Frame: At Month 13 and Month 25
At Month 13 and Month 25
Number of participants with plasma HIV-1 RNA <50 copies/mL as per observed data
Time Frame: At Month 7, Month 13 and Month 25
At Month 7, Month 13 and Month 25
Change from baseline (Day 1) in cluster of differentiation (CD) 4+ T-cell count
Time Frame: At Month 7, Month 13 and Month 25
At Month 7, Month 13 and Month 25
Number of participants with injection site reaction adverse events of special interest (ISR AESIs) by grade
Time Frame: Through Month 7, Month 13 and Month 25
The ISR AESIs will be graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table Version 2.1, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening.
Through Month 7, Month 13 and Month 25
Duration of ISR AESIs by grade
Time Frame: Through Month 7, Month 13 and Month 25
The ISR AESIs will be graded using the DAIDS grading table Version 2.1, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening.
Through Month 7, Month 13 and Month 25
Number of participants with serious adverse events (SAEs) by grade
Time Frame: Through Month 7, Month 13 and Month 25
An SAE is defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, caused a congenital anomaly/birth defect, or was any other situation identified according to medical or scientific judgment. The SAEs will be graded using the DAIDS grading table Version 2.1, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.
Through Month 7, Month 13 and Month 25
Number of participants with adverse events (AEs) leading to study treatment discontinuation, by grade
Time Frame: Through Month 7, Month 13 and Month 25
The AEs leading to treatment discontinuation will be graded using the DAIDS grading table Version 2.1, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.
Through Month 7, Month 13 and Month 25
Plasma concentrations of VH4011499
Time Frame: Through Months 7, 13 and 25
Through Months 7, 13 and 25

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViiV Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 19, 2026

Primary Completion (Estimated)

June 10, 2032

Study Completion (Estimated)

June 11, 2032

Study Registration Dates

First Submitted

September 6, 2026

First Submitted That Met QC Criteria

September 6, 2026

First Posted (Actual)

September 11, 2026

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 6, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 308532
  • 2026-526236-39 (Other Identifier: EU CT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer tohttps://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_28May2026.pdf

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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