Proof of concept treatment study of orally administered VH4004280 or VH4011499 in HIV-1 infected adults
- Conditions
- HIV InfectionsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- CTIS2023-505350-18-00
- Lead Sponsor
- Viiv Healthcare UK Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 43
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the antiviral activity of orally administered VH4004280 and VH4011499 monotherapy over 10 days in HIV-1 infected Treatment-Naïve participants;Secondary Objective: To assess the safety and tolerability of orally administered VH4004280 and VH4011499, To characterize the pharmacokinetic profiles of orally administered VH4004280 and VH4011499, To determine the relationship between the exposure levels of orally administered VH4004280 and VH4011499 and change in plasma HIV-1 RNA;Primary end point(s): Maximum change from baseline (Day 1) in plasma HIV-1 ribonucleic acid through Day 11.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):•Incidence of adverse events (AEs), severity of AEs and AEs leading to study treatment discontinuation •Change from baseline and maximum toxicity grade increase from baseline for liver panel laboratory parameters;Secondary end point(s):PK measures that include but are not limited to: •Maximum observed plasma drug concentration (Cmax), •Time to maximum observed plasma drug concentration (tmax), •Concentrations on Day 11 for VH4004280 and VH4011499;Secondary end point(s):VH4004280 and VH4011499 PK parameters with maximum change in plasma HIV-1 RNA from baseline through Day 11