HIV InfectionsPhase 2CINERGYNCT07816250
A Phase 2b Study Evaluating VH4011499 Capsid Inhibitor Long-Acting Injectable Plus Cabotegravir in Treatment Naïve Adults (CINERGY)
A Phase 2 study testing VH4011499, CAB and DTG/3TC in people with HIV Infections, run by ViiV Healthcare.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- VH4011499, CAB and DTG/3TC
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 19 Oct 2026to 11 Jun 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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)
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.
- Conditions
- HIV Infections
- Being tested
- VH4011499, CAB, DTG/3TC
- Keywords
- VH4011499, Cabotegravir (CAB), Dolutegravir/Lamivudine (DTG/3TC), Efficacy, People with HIV (PWH)
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VH4011499Drug
Participants receive injectable VH4011499 at different dose groups.
CABDrug
Participants receive injectable CAB.
DTG/3TCDrug
Participants receive DTG/3TC orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| VH4011499 dose Group 1 + CAB | Experimental | Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 1, which differs from all other arms) and cabotegravir (CAB). Receives: Drug: VH4011499; Drug: CAB |
| VH4011499 dose Group 2 + CAB | Experimental | Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 2, which differs from all other arms) and CAB. Receives: Drug: VH4011499; Drug: CAB |
| VH4011499 dose Group 3 + CAB | Experimental | Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 3, which differs from all other arms) and CAB. Receives: Drug: VH4011499; Drug: CAB |
| VH4011499 dose Group 4 + CAB | Experimental | Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 4, which differs from all other arms) and CAB. Receives: Drug: VH4011499; Drug: CAB |
| DTG/3TC | Active comparator | Active control arm receiving daily oral standard of care antiretroviral therapy (dolutegravir 50 mg / lamivudine 300 mg single-tablet regimen). Receives: Drug: DTG/3TC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with plasma HIV-1 RNA <50 copies/mL as per FDA snapshot algorithm
Measured: At Month 7
Secondary outcomes (8)
Number of participants with plasma HIV-1 RNA <50 copies/mL as per FDA snapshot algorithm
Measured: At Month 13 and Month 25
Number of participants with plasma HIV-1 RNA <50 copies/mL as per observed data
Measured: At Month 7, Month 13 and Month 25
Change from baseline (Day 1) in cluster of differentiation (CD) 4+ T-cell count
Measured: At Month 7, Month 13 and Month 25
Number of participants with injection site reaction adverse events of special interest (ISR AESIs) by grade
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.
Measured: Through Month 7, Month 13 and Month 25
Duration of ISR AESIs by grade
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.
Measured: Through Month 7, Month 13 and Month 25
Number of participants with serious adverse events (SAEs) by grade
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.
Measured: Through Month 7, Month 13 and Month 25
Number of participants with adverse events (AEs) leading to study treatment discontinuation, by grade
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.
Measured: Through Month 7, Month 13 and Month 25
Plasma concentrations of VH4011499
Measured: Through Months 7, 13 and 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start19 Oct 2026 (estimated)
- Primary completion10 Jun 2032 (estimated)
- Study completion11 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816250
- Sponsor's protocol ID
- 308532
- Other IDs
- 2026-526236-39
- Acronym
- CINERGY
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07816250
- Acronym / sponsor ID
- CINERGY / 308532
- Conditions
- HIV Infections
- Keywords
- VH4011499, Cabotegravir (CAB), Dolutegravir/Lamivudine (DTG/3TC), Efficacy, People with HIV (PWH)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- 10 Jun 2032 (estimated)
- Study completion
- 11 Jun 2032 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| VH4011499 dose Group 1 + CAB | Experimental | Drug: VH4011499, Drug: CABInvestigational long-acting injectable regimen consisting of VH4011499 (dose Group 1, which differs from all other arms) and cabotegravir (CAB). |
| VH4011499 dose Group 2 + CAB | Experimental | Drug: VH4011499, Drug: CABInvestigational long-acting injectable regimen consisting of VH4011499 (dose Group 2, which differs from all other arms) and CAB. |
| VH4011499 dose Group 3 + CAB | Experimental | Drug: VH4011499, Drug: CABInvestigational long-acting injectable regimen consisting of VH4011499 (dose Group 3, which differs from all other arms) and CAB. |
| VH4011499 dose Group 4 + CAB | Experimental | Drug: VH4011499, Drug: CABInvestigational long-acting injectable regimen consisting of VH4011499 (dose Group 4, which differs from all other arms) and CAB. |
| DTG/3TC | Active comparator | Drug: DTG/3TCActive control arm receiving daily oral standard of care antiretroviral therapy (dolutegravir 50 mg / lamivudine 300 mg single-tablet regimen). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VH4011499Participants receive injectable VH4011499 at different dose groups. | Drug | VH4011499 dose Group 1 + CAB, VH4011499 dose Group 2 + CAB, VH4011499 dose Group 3 + CAB, VH4011499 dose Group 4 + CAB |
| CABParticipants receive injectable CAB. | Drug | VH4011499 dose Group 1 + CAB, VH4011499 dose Group 2 + CAB, VH4011499 dose Group 3 + CAB, VH4011499 dose Group 4 + CAB |
| DTG/3TCParticipants receive DTG/3TC orally once daily. | Drug | DTG/3TC |
Primary outcome
Number of participants with plasma HIV-1 RNA <50 copies/mL as per FDA snapshot algorithm
Time frame: At Month 7
8 secondary outcomes
Number of participants with plasma HIV-1 RNA <50 copies/mL as per FDA snapshot algorithm
Time frame: 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
Change from baseline (Day 1) in cluster of differentiation (CD) 4+ T-cell count
Time frame: 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
Duration of ISR AESIs by grade
Time frame: 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
Number of participants with adverse events (AEs) leading to study treatment discontinuation, by grade
Time frame: Through Month 7, Month 13 and Month 25
Plasma concentrations of VH4011499
Time frame: Through Months 7, 13 and 25
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VH4011499, CAB and DTG/3TC in people with HIV Infections, run by ViiV Healthcare.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with plasma HIV-1 RNA <50 copies/mL as per FDA snapshot algorithm (time frame: At Month 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.