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New treatment option for HIV Infections
Official title A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)
ClinicalTrials.gov ID: NCT07202546
What this study is testing
What is VH4524184?
VH4524184 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hiv infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection. The study is comparing two different doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide (FTC/TAF), to a standard HIV treatment called dolutegravir and lamivudine (DTG/3TC).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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 \>200 cells/microlitre (µL).
- Documented HIV-1 infection and Screening plasma HIV-1 RNA of ≥1000 copies/millilitre (mL). A single repeat of this test is allowed within a single...
- Treatment-naive: Defined as no ARVs (in combination or monotherapy) received after the diagnosis of HIV-1 infection.
- Body weight \>=50.0 kilogram (kg) [(110 pounds (lbs)] for participants assigned male at birth and \>=45.0 kg (99 lbs) for participants assigned...
You likely can't join if
- Participants who are breastfeeding or plan to breastfeed during the study.
- Participants with acute HIV infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue, etc.) and/or evidence of recent (within...
- Any evidence of an active Centres for Disease Control and Prevention (CDC) Stage 3 disease [CDC 2014], except cutaneous Kaposi's sarcoma not...
- Unstable liver disease known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic...
- History of cirrhosis with or without viral hepatitis co-infection.
- Participants with HCV co-infection will be excluded from the study.
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 \>200 cells/microlitre (µL).
- Documented HIV-1 infection and Screening plasma HIV-1 RNA of ≥1000 copies/millilitre (mL). A single repeat of this test is allowed within a single Screening period to determine eligibility.
- Treatment-naive: Defined as no ARVs (in combination or monotherapy) received after the diagnosis of HIV-1 infection.
- Body weight \>=50.0 kilogram (kg) [(110 pounds (lbs)] for participants assigned male at birth and \>=45.0 kg (99 lbs) for participants assigned female at birth. BMI within the range 18.5-35.5 kg/m\^2 (inclusive -...
- 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 or breastfeeding and one of the following conditions applies:
- Is a Participant of non-childbearing potential (PONCBP);OR Is a Participant of childbearing potential (POCBP) and using a contraceptive method with a failure rate of less than (\<) 1% prior to and during the study...
- A POCBP must have a negative 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. Participant with a positive serum test must be excluded.
- Capable of giving signed informed consent.
What rules you out
- Participants who are breastfeeding or plan to breastfeed during the study.
- 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...
- Any evidence of an active Centres for Disease Control and Prevention (CDC) Stage 3 disease [CDC 2014], except cutaneous Kaposi's sarcoma not requiring systemic therapy during the study. Historical CD4+ cell counts less...
- Unstable liver disease known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
- 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 Participants diagnosed with syphilis at Screening (i.e., positive syphilis testing) should be treated as per local guidelines and will be eligible to...
- 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...
- Any condition which, in the opinion of the investigator or the ViiV Healthcare medical monitor, that may interfere with the absorption, distribution, metabolism or excretion of the study interventions or render the...
- 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...
- Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.
- 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...
- 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...
- Treatment with any of the following agents within 60 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any systemic immune suppressant.
- 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.
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
- 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...
- Creatinine clearance (eGFR) of \<60 mL/min/1.73 m2 via CKD-EPI race neutral method [Delgado, 2021].
- ALT \>3 times the upper limit of normal (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...
- Any acute laboratory abnormality at screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bakersfield, California, United States
- Palm Springs, California, United States
- West Hollywood, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Ft. Pierce, Florida, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- Miami Gardens, Florida, United States
- Oakland Park, Florida, United States
- Orlando, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Macon, Georgia, United States
- Louisville, Kentucky, United States
- Columbia, Missouri, United States
- Kansas City, Missouri, United States
- Omaha, Nebraska, United States
- Newark, New Jersey, United States
- Albany, New York, United States
+ 67 more site(s).
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bakersfield, California, United States; Palm Springs, California, United States; West Hollywood, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; Ft. Pierce, Florida, United States and 81 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.