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A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons with HIV-1 (INNOVATE Study)
EU CTIS ID: 2025-521918-26-00
What this study is testing
To evaluate the antiviral efficacy of oral VH4524184 containing regimens compared to DTG/3TC FDC oral control arm in treatment naïve viremic adults living with HIV-1
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant must be at least 18 years of age (or older, if required for adults by local regulations) at the time of signing the informed consent.
- Screening CD4+ T-cell count greater than or equal to 200 cells/µL.
- Documented HIV-1 infection and Screening plasma HIV-1 RNA of ≥1000 copies/mL. A single repeat of this test is allowed within a single Screening period to determine eligibility.
- Treatment-naïve: Defined as no ARVs (in combination or monotherapy) received after the diagnosis of HIV-1 infection. The prior use of oral pre-exposure prophylaxis or oral post-exposure prophylaxis is permitted and meets inclusion. (Note: Prior use of LA CAB is exclusionary)
- France: Participants enrolled in France must be affiliated with, or be a beneficiary of a social security system
- Body weight greater than or equal to 50.0 kg (110 lbs) for participants assigned male at birth and greater than or equal to 45.0 kg (99 lbs) for participants assigned female at birth. BMI within the range 18.5-35.5 kg/m2 (inclusive - applies to males and females).
You likely can't join if
- Participants who are breastfeeding or plan to breastfeed during the study.
- ALT > or = 3 times the ULN. A single repeat of ALT is allowed within a single screening period to determine eligibility.
- Any Grade 4 laboratory abnormality at Screening, except for a Grade 4 CPK and lipid abnormalities (e.g., total cholesterol, triglycerides, etc.) will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the ViiV Healthcare medical monitor. A single repeat of any lab abnormality is allowed within a single screening period to determine eligibility.
- Participants who in the investigator’s judgment, pose a significant suicidality risk. Participant’s history of suicidal behavior and/or suicidal ideation (as measured with the C-SSRS prior to dosing) should be considered when evaluating suicide risk.
- Any acute laboratory abnormality at Screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.
- Any evidence of an active CDC Stage 3 disease [CDC 2014], except cutaneous Kaposi’s sarcoma not requiring systemic therapy during the study. Historical CD4+ cell counts less than 200 cells/µL are not exclusionary.
See the full eligibility criteria
Who can join
- Participant must be at least 18 years of age (or older, if required for adults by local regulations) at the time of signing the informed consent.
- Screening CD4+ T-cell count greater than or equal to 200 cells/µL.
- Documented HIV-1 infection and Screening plasma HIV-1 RNA of ≥1000 copies/mL. A single repeat of this test is allowed within a single Screening period to determine eligibility.
- Treatment-naïve: Defined as no ARVs (in combination or monotherapy) received after the diagnosis of HIV-1 infection. The prior use of oral pre-exposure prophylaxis or oral post-exposure prophylaxis is permitted and meets inclusion. (Note: Prior use of LA CAB is exclusionary)
- France: Participants enrolled in France must be affiliated with, or be a beneficiary of a social security system
- Body weight greater than or equal to 50.0 kg (110 lbs) for participants assigned male at birth and greater than or equal to 45.0 kg (99 lbs) for participants assigned female at birth. BMI within the range 18.5-35.5 kg/m2 (inclusive - applies to males and females).
- There are no contraceptive requirements for participants assigned male at birth.
- Participants assigned female at birth are eligible to participate if they are not pregnant and not breastfeeding and one of the following conditions applies: • Is a PONCBP; OR • Is a POCBP and using a contraceptive method that is highly effective, with a failure rate of <1% (see Section 10.4.2) prior to and during the study intervention period, and for at least 1 week after the last dose of VH4524184 plus FTC/TAF FDC, or through the end of study (if in the control arm and never received VH4524184). The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention. - A POCBP must have a negative highly sensitive pregnancy test at Screening (serum) and on Day 1 (urine) before the first dose of study intervention. - If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. - The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of an individual with an early undetected pregnancy.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and stated in this protocol.
What rules you out
- Participants who are breastfeeding or plan to breastfeed during the study.
- ALT > or = 3 times the ULN. A single repeat of ALT is allowed within a single screening period to determine eligibility.
- Any Grade 4 laboratory abnormality at Screening, except for a Grade 4 CPK and lipid abnormalities (e.g., total cholesterol, triglycerides, etc.) will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the ViiV Healthcare medical monitor. A single repeat of any lab abnormality is allowed within a single screening period to determine eligibility.
- Participants who in the investigator’s judgment, pose a significant suicidality risk. Participant’s history of suicidal behavior and/or suicidal ideation (as measured with the C-SSRS prior to dosing) should be considered when evaluating suicide risk.
- Any acute laboratory abnormality at Screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.
- Any evidence of an active CDC Stage 3 disease [CDC 2014], except cutaneous Kaposi’s sarcoma not requiring systemic therapy during the study. Historical CD4+ cell counts less than 200 cells/µL are not exclusionary.
- Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination and will be the screening ECG entered into the eCRF): QT interval corrected for heart rate according to Fridericia’s formula (QTcF) >450 msec (males) or >470 msec (females); >480 msec for participants with bundle branch block.
- Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
- Known history of cirrhosis with or without viral hepatitis co-infection.
- Participants with HCV co-infection will be excluded from the study.
- Individuals who are co-infected with HIV and HBV will be excluded. Exclusion will be determined by evidence of HBV infection based on the results of testing at Screening for HBsAg, HBcAb, HBsAb and HBV DNA as follows: a. Participants positive for HBsAg are excluded; b. Participants negative for HBsAb and negative for HBsAg but positive for HBcAb may be excluded based on the following. Consideration: i. Exclude if HBV DNA is detected (either < LLOQ, > ULOQ OR numerical value [ie, between LLOQ and ULOQ]) ii. Not excluded if HBV DNA is negative, not detected Note: Participants positive for HBcAb, negative for HBsAg and positive for HBsAb (past and/or current evidence, e.g., at screening) are considered to be immune to HBV and are not excluded.
- Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 30 days of Day 1.
- Participants diagnosed with syphilis at Screening (i.e., positive syphilis testing) should be treated as per local guidelines and will be eligible to enroll at any time regardless of the stage of disease. When RPR or VDRL titers are high (i.e., ≥1:256), investigators should consider syphilis treatment before study enrollment, but may enroll 48 hours after treatment initiation.
- Uncontrolled malignancy is excluded, whereas participants who have controlled malignancies may be included in agreement between the investigator and the ViiV Healthcare medical monitor.
- Any pre-existing physical, or mental condition (including alcohol or drug abuse) which, in the opinion of the investigator (with or without psychiatric evaluation) or the ViiV Healthcare medical monitor, may interfere with the participant’s ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
- Any condition which, in the opinion of the investigator or the ViiV Healthcare medical monitor, may interfere with the absorption, distribution, metabolism or excretion of the study interventions or render the participant unable to take oral medication.
- A pre-existing condition, in the opinion of the investigator or ViiV Healthcare medical monitor, that could interfere with normal gastrointestinal anatomy or motility (e.g., gastroesophageal reflux disease, gastric ulcers, gastritis, inflammatory bowel disease) or hepatic and/or renal function
- Clinically significant CV disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease.
- History of sensitivity to any of the study medications, or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or ViiV Healthcare medical monitor, contraindicates their participation.
- Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (≤325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.
- Treatment with any of the following agents within 60 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any systemic immune suppressant.
- Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.
- Participants with acute HIV infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue, etc.) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion.
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
- Exposure to an investigational drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of study intervention.
- Exposure to an approved vaccine within 14 days prior to Day 1.
- Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research.
- Participants with known or suspected presence of virologic resistance mutations as defined by the Stanford HIV Drug Resistance Database to INSTIs or NRTIs. This determination will be based on local virologic resistance testing, either at Screening or within the 3 months prior to Screening. ViiV Healthcare clinical virologist and/or ViiV Healthcare medical monitor will verify eligibility to this criterion prior to Day 1.
- Creatinine clearance (eGFR) of <60 mL/min/1.73 m2 via CKD-EPI race neutral method [Delgado, 2021]. • Japan: For Japanese participants enrolled at sites in Japan, the eGFR will be calculated using the serum creatinine-based Japanese eGFR estimation formula (JSN eGFRcr) recommended by the Japanese Society of Nephrology [Japanese Society of Nephrology, 2024].
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Argentina
- Korea, Republic of
- United States
- Japan
- Canada
- United Kingdom
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Argentina; Korea, Republic of; United States; Japan; Canada and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.