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PH2a, VH4524184 Proof-of-Concept in Treatment-Naïve Adults Living with HIV-1
EU CTIS ID: 2023-507173-18-00
What this study is testing
To evaluate the antiviral activity of VH4524184 in Treatment Naïve participants with HIV-1 during 10 days of monotherapy
- 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 18 to 65 years of age inclusive at the time of signing the informed consent.
- If a urine test cannot be confirmed as negative (e.g. 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 risk for inclusion of a female with an early undetected pregnancy.
- Capable of giving signed informed consent
- Participant must be willing and able to start standard-of-care ART as selected with the investigator on Study Day 10.
- Participants who are overtly healthy (other than HIV infection) as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
You likely can't join if
- Participants with primary HIV infection.
- Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing. Specific medications listed in Section 6.9.1 may be allowed.
- Participants who require concomitant medications known to be associated with a prolonged QTc.
- Participants receiving any protocol-prohibited medication(s) and who are unwilling or unable to switch to an alternate medication).
- The participant has ever received an investigational HIV vaccine (immunotherapeutic or immunomodulatory).
- Exposure to an experimental drug or experimental vaccine within either 30 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.
See the full eligibility criteria
Who can join
- Participant must be 18 to 65 years of age inclusive at the time of signing the informed consent.
- If a urine test cannot be confirmed as negative (e.g. 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 risk for inclusion of a female with an early undetected pregnancy.
- Capable of giving signed informed consent
- Participant must be willing and able to start standard-of-care ART as selected with the investigator on Study Day 10.
- Participants who are overtly healthy (other than HIV infection) as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Positive HIV antibody test
- Documented HIV infection and Screening plasma HIV-1 RNA ≥ 3,000 copies/mL. A single repeat of this test is allowed within a single Screening period to determine eligibility.
- Screening CD4+ T-cell count ≥200 cells/mm3
- Treatment-naïve: No antiretrovirals (ARVs, in combination or monotherapy) received after the diagnosis of HIV-1 infection.
- HIV Pre-exposure or post-exposure prophylaxis: No prior use of any INSTI (including cabotegravir) for HIV pre-exposure or post-exposure prophylaxis.
- Body weight ≥50.0 kg (110 lbs.) for men and ≥45.0 kg (99 lbs) for women and BMI within the range 18.5-31.0 kg/m2 (inclusive - applies to males and females).
- A participant of childbearing potential must have a negative serum hCG test at screening, and negative urine hCG test at Day 1, before the first dose of study intervention.
What rules you out
- Participants with primary HIV infection.
- Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing. Specific medications listed in Section 6.9.1 may be allowed.
- Participants who require concomitant medications known to be associated with a prolonged QTc.
- Participants receiving any protocol-prohibited medication(s) and who are unwilling or unable to switch to an alternate medication).
- The participant has ever received an investigational HIV vaccine (immunotherapeutic or immunomodulatory).
- Exposure to an experimental drug or experimental vaccine within either 30 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.
- Participation in the study would result in donation of blood in excess of 500 mL within 56 days.
- Exposure to more than four new investigational drugs or vaccines within 12 months prior to the first dosing day.
- Current enrollment or past participation within the last 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research.
- Diagnostic Assessments: • Presence of HBsAg or HBcAb at screening • Positive Hepatitis C antibody test result at Screening • Positive Hepatitis C RNA test result at Screening. • Creatinine clearance (eGFR) of < 60 mL/min/1.73 m2 using CKD-EPI equation (2021)
- Any evidence of an active CDC Stage 3 disease, except cutaneous Kaposi’s sarcoma not requiring systemic therapy during the study.
- Untreated syphilis infection [positive RPR at screen] without documentation of treatment.
- Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia; or other localized malignancies
- Any pre-existing physical or mental condition which, in the opinion of the Investigator, 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 history of significant underlying psychiatric disorder, or a clinical assessment of suicidality based on the responses on the eCSSRS.
- Any history of major depressive disorder with or without suicidal features, or anxiety disorders, that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (>6 months) outpatient treatment.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome or sudden cardiac death. 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 study drug administration.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Mexico
- Argentina
- Canada
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 United States; Mexico; Argentina; Canada. 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.