A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1
- Registration Number
- NCT06061081
- Lead Sponsor
- ViiV Healthcare
- Brief Summary
The primary purpose of this study is to assess the antiviral activity of VH3739937 in Human Immunodeficiency Virus Type-1 (HIV-1) infected treatment naive (TN) participants during monotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
- 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
- Treatment-naïve: No Antiretrovirals (ARVs) (in combination or monotherapy) received after the diagnosis of HIV-1 infection
- Body weight ≥50.0 kilogram (kg) (110 pounds [lbs]) for men and ≥45.0 kg (99 lbs) for women and BMI for all participants within the range 18.5-35.0 kilogram per meter square (kg/m^2).
- Capable of giving signed informed consent
- Participant must be willing and able to start Combination Antiretrovial Therapy (cART) as selected with the Investigator on Study Day 8 (except in the case of early termination, clinically relevant AE/SAE, lab abnormality, the withdrawal of consent, lost to follow-up, etc., where circumstances could dictate otherwise).
Exclusion Criteria
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- Participants with primary 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 evidence of recent (within 3 months) documented seroconversion
- Myocardial infarction, acute coronary syndrome, unstable angina, stroke, transient ischemic attack, or intermittent claudication in the past 3 months
- The participant has received an investigational HIV vaccine (immunotherapeutic or immunomodulatory)
- Regular use of drugs of abuse
- Sensitivity to heparin or heparin-induced thrombocytopenia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Participants receiving VH3739937 VH3739937 - Participants receiving Placebo Placebo -
- Primary Outcome Measures
Name Time Method Maximum Change from Baseline in Plasma HIV-1 Ribonucleic Acid (RNA) Baseline (Day 1) and up to Day 8
- Secondary Outcome Measures
Name Time Method Time to maximum observed concentration (Tmax) of VH3739937 at Day 1 Day 1 Area under the concentration-time curve from zero to 24h of VH379937 at steady state Day 7 Concentration of VH3739937 at 168 h after single dose At 168 hours Area under the concentration-time curve from zero to 24h of VH3739937 at Day 1 Day 1 Concentration at 24 h post dose of VH3739937 at steady state Day 7 Maximum observed concentration of VH3739937 after single dose Up to 168 hours Number of Participants with Serious Adverse Events, Deaths, or Adverse Events leading to Discontinuation Up to Day 8 Concentration at 24 hours (h) post dose of VH3739937 at Day 1 Day 1 Maximum observed concentration of VH3739937 at Day 1 Day 1 Time to maximum observed concentration (Tmax) of VH3739937 at steady state Day 7 Time to maximum observed concentration (Tmax) of VH3739937 after single dose Up to 168 hours Area under the concentration-time curve of VH3739937 from zero to 168h after single dose Up to 168 hours Maximum observed concentration of VH3739937 at steady state Day 7
Trial Locations
- Locations (1)
GSK Investigational Site
🇪🇸Vitoria, Spain