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Proof of concept treatment study of orally administered VH4004280 or VH4011499 in HIV-1 infected adults
EU CTIS ID: 2023-505350-18-00
What this study is testing
To evaluate the antiviral activity of orally administered VH4004280 and VH4011499 monotherapy over 10 days in HIV-1 infected Treatment-Naïve participants
- 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
- Are 18 to 65 years of age
- Are overtly healthy (other than HIV-1 infection)
- Have screening CD4+ T-cell counts >=200 cells/µL.
- Have documented HIV-1 infection and Screening plasma HIV-1 RNA >=3000 copies/mL
- Are treatment-naïve: Prior use of oral PreP is permitted and meets inclusion. Prior use of parenteral PreP is exclusionary
- Has BMI within the range 18.5-31.0 kg/m2.
You likely can't join if
- Are breastfeeding or plan to become pregnant or breast feed during the study.
- Has untreated syphilis infection.
- Is positive for hepatitis B or hepatitis C.
- Has exclusionary safety laboratory (e.g Grade 3 or greater abnormality).
- Is positive result for illicit drug use, regular use of drugs of abuse and/or excessive alcohol use
- Participants with acute HIV infection
See the full eligibility criteria
- Are 18 to 65 years of age
- Are overtly healthy (other than HIV-1 infection)
- Have screening CD4+ T-cell counts >=200 cells/µL.
- Have documented HIV-1 infection and Screening plasma HIV-1 RNA >=3000 copies/mL
- Are treatment-naïve: Prior use of oral PreP is permitted and meets inclusion. Prior use of parenteral PreP is exclusionary
- Has BMI within the range 18.5-31.0 kg/m2.
- Participants male at birth must use male condoms and participants female at birth who are of childbearing potential must be using acceptable forms of birth control
- Are capable of giving signed informed consent
- Are willing and able to start locally accessible and commercially available combination antiretroviral therapy on Study Day 11.
- Are breastfeeding or plan to become pregnant or breast feed during the study.
- Has untreated syphilis infection.
- Is positive for hepatitis B or hepatitis C.
- Has exclusionary safety laboratory (e.g Grade 3 or greater abnormality).
- Is positive result for illicit drug use, regular use of drugs of abuse and/or excessive alcohol use
- Participants with acute HIV infection
- Any evidence of an active CDC Stage 3 disease.
- Ongoing malignancy other than certain localized malignancies
- Treatment with immunomodulating agents or any agent with known anti-HIV activity.
- Has exclusionary psychiatric, hepatic, cardiovascular gastrointestinal, renal condition
- Has a condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to take the medication.
- Has an exclusionary ECG finding.
- Has been exposed to any prohibited medication or vaccine.
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- United Kingdom
- Canada
- Mexico
- United States
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 Argentina; United Kingdom; Canada; Mexico; United States. 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.