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NCT Number: NCT07816250

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

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VH4011499

Drug

Participants receive injectable VH4011499 at different dose groups.

CAB

Drug

Participants receive injectable CAB.

DTG/3TC

Drug

Participants receive DTG/3TC orally once daily.

Primary outcomes

  1. Number of participants with plasma HIV-1 RNA <50 copies/mL as per FDA snapshot algorithm

    Time frame: At Month 7

Secondary outcomes

  1. Number of participants with plasma HIV-1 RNA <50 copies/mL as per FDA snapshot algorithm

    Time frame: At Month 13 and Month 25

  2. 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

  3. Change from baseline (Day 1) in cluster of differentiation (CD) 4+ T-cell count

    Time frame: At Month 7, Month 13 and Month 25

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Plasma concentrations of VH4011499

    Time frame: Through Months 7, 13 and 25

Study contacts

Contact information is provided by the study sponsor or research team.

EU GSK Clinical Trials Call Center

CONTACT

[email protected]

+44 (0) 20 89904466

US GSK Clinical Trials Call Center

CONTACT

[email protected]

877-379-3718

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Registry information

Official study title

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)

Acronym: CINERGY

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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