Clinical trial 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 oral tablet being studied as a potential treatment for HIV-1 in adults who have never received treatment.
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
- The study compares two doses of VH4524184 plus FTC/TAF to a standard HIV treatment to see how well the new drug works over time and to help decide future dosing.
- Who it's for
- Adults with HIV-1 who have never received any HIV treatment.
- What's involved
- Participants will take either VH4524184 with FTC/TAF or the standard DTG/3TC, attend clinic visits, and have blood tests to monitor the virus and drug safety.
- Time commitment
- The study lasts several months, with regular clinic visits and blood tests as scheduled by the research team.
- 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).
- 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.
- There are no contraceptive requirements for participants assigned male at birth.
- 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. Persons who are placed in an institution by order of a public authority or a court are excluded from participation in this study.
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.
- 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.
- 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 is enrolling
- 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
- Chicago, Illinois, United States
- Columbia, Missouri, United States
- Kansas City, Missouri, United States
- Omaha, Nebraska, United States
- Hackensack, New Jersey, United States
- Newark, New Jersey, United States
+ 76 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, but 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?
This study is enrolling now at 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 90 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.