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PH2a, VH3739937 Proof-Of-Concept in TN HIV-1 Infected Adults
EU CTIS ID: 2023-505780-37-00
What this study is testing
To evaluate the antiviral activity of VH3739937 in HIV-1 infected treatment-naive (TN) participants during 7 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
- Participants aged 18 to 65 years of age inclusive at the time of signing the informed consent
- Participant must be willing and able to start a commercially available standard of care antiretroviral treatment regimen on Study Day 8 .
- Participants who are overtly healthy (other than HIV infection)
- Screening CD4+ T-cell count >=200 cells/mm3
- Documented HIV infection and Screening plasma HIV-1 RNA >=3000 and <1,000,000 copies/mL.
- Positive HIV antibody test
You likely can't join if
- Any evidence of an active CDC Stage 3 disease
- Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome or sudden cardiac death. Has an exclusionary ECG finding.
- Previous exposure to a maturation inhibitor
- Has been exposed to any prohibited or exclusionary medication or vaccine.
- History of sensitivity to any of the study interventions or their components.
- Exposure to an experimental medication or vaccine within 28 days or 5 half-lives (which is longer) before the first dose of study intervention.
See the full eligibility criteria
- Participants aged 18 to 65 years of age inclusive at the time of signing the informed consent
- Participant must be willing and able to start a commercially available standard of care antiretroviral treatment regimen on Study Day 8 .
- Participants who are overtly healthy (other than HIV infection)
- Screening CD4+ T-cell count >=200 cells/mm3
- Documented HIV infection and Screening plasma HIV-1 RNA >=3000 and <1,000,000 copies/mL.
- Positive HIV antibody test
- Treatment naive: No antiretroviral therapies (in combination or monotherapy) received after HIV-1 diagnosis
- Body weight ≥50.0 kg (110 lbs.) for men and ≥45.0 kg (99 lbs) for women and BMI for all participants within the range 18.5-35.0 kg/m2
- Participants who were considered female at birth must be of non-childbearing potential
- Capable of giving signed informed consent
- Any evidence of an active CDC Stage 3 disease
- Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome or sudden cardiac death. Has an exclusionary ECG finding.
- Previous exposure to a maturation inhibitor
- Has been exposed to any prohibited or exclusionary medication or vaccine.
- History of sensitivity to any of the study interventions or their components.
- Exposure to an experimental medication or vaccine within 28 days or 5 half-lives (which is longer) before the first dose of study intervention.
- Has untreated syphilis infection
- Is positive for Hepatitis B or C
- Has exclusionary safety laboratory test results (e.g., Grade 3 or greater abnormality)
- Has a positive result for illicit drug use, regular use of drugs of abuse
- Sensitivity to heparin or heparin-induced thrombocytopenia
- Ongoing malignancy other than certain localized malignancies
- History of significant underlying psychiatric disorder or a clinical assessment of suicidality. History of suicidal behavior and/or ideation should be considered when evaluating suicide risk
- History of major depressive disorder with or without suicidal features, or anxiety disorders that required medical intervention.
- Any pre-existing physical or other psychiatric condition (including alcohol or drug abuse) which may interfere with participant's ability to comply with the protocol and dosing schedule
- Current or chronic history of liver disease
- Primary HIV infection
- Pre-existing condition that could interfere with normal gastrointestinal anatomy or motility, hepatic and/or renal function that could impact the absorption, metabolism, and/or excretion of the study interventions.
- Myocardial infarction, acute coronary syndrome, unstable angina, stroke, TIA, or intermittent claudication in the past 3 months.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Argentina
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Argentina. 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.