A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1

September 22, 2023 updated by: ViiV Healthcare

A Randomized, Double-Blind (Sponsor-Unblinded), Placebo-Controlled, Adaptive Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in Treatment-Naïve Adults Living With HIV-1

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1181ACH
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marisa Sanchez
    • Cordoba
      • Villa María, Cordoba, Argentina, X5900
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Darío Quinodoz
    • Córdova
      • Cordoba, Córdova, Argentina, X5016KEH
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pablo Sanchez
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sergio Lupo
  • Greece
      • Athens, Greece, 10676
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vassilios Papastamopoulos
      • Athens, Greece, 12462
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antonios Papadopoulos
  • Italy
      • Milano, Italy, 20142
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Teresa Bini
    • Emilia Romagna
      • Modena, Emilia Romagna, Italy, 41124
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cristina Mussini
    • Lazio
      • Roma, Lazio, Italy, 00133
        • GSK Investigational Site
        • Principal Investigator:
          • Loredana Sarmati
        • Contact:
        • Contact:
    • Liguria
      • Genova, Liguria, Italy, 16132
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antonio Di Biagio
    • Lombardia
      • Brescia, Lombardia, Italy, 25123
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francesco Castelli
  • Poland
      • Szczecin, Poland, 71- 455
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Milosz Parczewski
      • Warszawa, Poland, 01-201
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ewa Siwak
  • United States
    • California
      • Bakersfield, California, United States, 93301
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Franco Antoni Felizarta
    • Florida
      • Miami, Florida, United States, 33136
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dushyantha Jayaweera
      • West Palm Beach, Florida, United States, 33401
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Moti N Ramgopal
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jihad Slim
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Linda Gorgos
    • Texas
      • Dallas, Texas, United States, 75246
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Uriel S Sandkovsky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Participants receiving Placebo
Drug: Placebo
Placebo will be administered.
Experimental: Participants receiving VH3739937
Drug: VH3739937
VH3739937 will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Change from Baseline in Plasma HIV-1 Ribonucleic Acid (RNA)
Time Frame: Baseline (Day 1) and up to Day 8
Baseline (Day 1) and up to Day 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Serious Adverse Events, Deaths, or Adverse Events leading to Discontinuation
Time Frame: Up to Day 8
Up to Day 8
Maximum observed concentration of VH3739937 at Day 1
Time Frame: Day 1
Day 1
Time to maximum observed concentration (Tmax) of VH3739937 at Day 1
Time Frame: Day 1
Day 1
Concentration at 24 hours (h) post dose of VH3739937 at Day 1
Time Frame: Day 1
Day 1
Area under the concentration-time curve from zero to 24h of VH3739937 at Day 1
Time Frame: Day 1
Day 1
Maximum observed concentration of VH3739937 at steady state
Time Frame: Day 7
Day 7
Time to maximum observed concentration (Tmax) of VH3739937 at steady state
Time Frame: Day 7
Day 7
Concentration at 24 h post dose of VH3739937 at steady state
Time Frame: Day 7
Day 7
Area under the concentration-time curve from zero to 24h of VH379937 at steady state
Time Frame: Day 7
Day 7
Maximum observed concentration of VH3739937 after single dose
Time Frame: Up to 168 hours
Up to 168 hours
Time to maximum observed concentration (Tmax) of VH3739937 after single dose
Time Frame: Up to 168 hours
Up to 168 hours
Area under the concentration-time curve of VH3739937 from zero to 168h after single dose
Time Frame: Up to 168 hours
Up to 168 hours
Concentration of VH3739937 at 168 h after single dose
Time Frame: At 168 hours
At 168 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViiV Healthcare

Investigators

  • Study Director: GSK Clinical Trials, ViiV Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 3, 2023

Primary Completion (Estimated)

June 26, 2024

Study Completion (Estimated)

June 26, 2024

Study Registration Dates

First Submitted

September 22, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 212580
  • 2023-505780-37-00 (Other Identifier: European Medicines Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe