NCT07816250Not yet recruitingPhase 2
A Phase 2b Study Evaluating VH4011499 Capsid Inhibitor Long-Acting Injectable Plus Cabotegravir in Treatment Naïve Adults (CINERGY)
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)
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 6 Sept 2026
- Start date
- 19 Oct 2026
- Primary completion date
- 10 Jun 2032
- Lead sponsor
- ViiV Healthcare
- Diseases
- HIV
- NCT number
- NCT07816250
- EudraCT number
- 2026-526236-39
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- From 19 Oct 2026 to the primary completion date, 10 Jun 2032
- No sites listed in no country
- 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
- 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
Other illness
- Participants with acute HIV-1 infection
- Unstable liver disease
- Participants with HCV co-infection
- Participant has evidence of chronic active HBV infection
- Clinically significant cardiovascular disease
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.